Preterm BirthNCT03460496
Transition to Home (TtH) After Preterm Birth
A study testing neonatologists, psychological support and lactation consultant in people with Preterm Birth, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Preterm birth is associated with significant and often life-long developmental, emotional and financial burdens. Preterm infants face several challenges that continue late into life, including developmental delays, social, and behavioural problems and poor academic performance. Read more about this study
- Who is it for?
- Ages 24 to 35 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- neonatologists, psychological support and lactation consultant
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 35 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Families of preterm infants (between 24 0/7 weeks and 34 6/7 weeks of gestation) born and hospitalized in the University Hospital Bern
- Infants will need to be discharged directly from the Neonatology department, and their parents must reside in Canton Bern, and speak German, French or English.
- For multiple births, all infants will be followed.
- Written informed consent by the parents
Who cannot join
- Preterm infants with congenital heart malformations and other congenital problems evident at birth
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Universitätsklinik für Kinderheilkunde Neonatologie Inselspital
Bern, 3010
Natascha Schuetz Haemmerli, MScN, +41 31 848 47 13, natascha.schuetz@insel.ch
Liliane Stoffel, MScN, +41 31 632 14 15, liliane.stoffelzuercher@insel.ch
About this study
Official title: Transition to Home (TtH) After Preterm Birth: Pilot Testing an Advanced Practice Nurse (APN)-Led Model of Transitional Care
Preterm birth is associated with significant and often life-long developmental, emotional and financial burdens. Preterm infants face several challenges that continue late into life, including developmental delays, social, and behavioural problems and poor academic performance. Parents also suffer considerable emotional and physical stress which in turn can have a negative impact on the child's development.
In Switzerland, during the transition from hospital to home, there are not many interventions intended to improve mental health outcomes in parents or to promote positive parenting to improve developmental outcomes for the preterm infant. There are also few interventions to reduce associated health care costs.
Read more
In order to improve parent and preterm infant outcomes, reduce hospital stay in the neonatal intensive care unit (NICU), lower readmission rates, and avoid unnecessary use of primary care resources a unique, new model of transitional care was developed. The new 'Transition to Home' (TtH) model makes use of well-tested, successful methods of post-discharge care.
The investigators' study will evaluate the organizational and financial feasibility and cost effectiveness of the TtH model for infants born preterm by measuring the impact of an Advanced Practice Nurse (APN)-led intervention at the Children's University Hospital Bern. The intervention focuses on improving parental mental health and well-being, on infant growth and development, and on lowering overall costs. The investigators will gather data and then adapt and test the model within a longitudinal interventional comparative effectiveness study, and prepare it for other Cantons in Switzerland to implement.
Read the detailed description
In The investigators' model, the APN will participate in comprehensively planning individual discharge, coordinating services, consulting with other healthcare professionals, assessing needs on a case by case basis, and coaching the family from birth to 6 months after discharge from the NICU. The APN will be supported by specialized neonatology nurses; together, they will form the Advanced Nursing Practice Team (ANP Team). Currently, 4 APNs are in training for the project.
The most important tasks of the APN are listed below:
- at birth and during initial hospitalization: first contact of the APN with the family, followed by regular visits, consultations, and educational training for and coordination with other services like lactation consultant, psychologist, social support etc. The APN will conduct family interviews at regular intervals, consult with and train parents on predefined topics in a structured manner while closely collaborating with nursing and medical staff. The APN will take a family-centred approach to making joint decisions. The APN will coordinate health care providers, encourage information flow and collaboration between the professionals as well as organize and manage regular interprofessional exchanges.
- discharge from the hospital: the APN will plan the comprehensive discharge together with parents and the interprofessional team.
- at home: the APN will make systematic follow-up after discharge. The APN will also offer telephone support for requests and answer parent's questions. They will also make follow-up home visits to assess the situation, including assessing physical and mental well-being of parents and infants. The APN will evaluate the interventions the family requested, discuss them with the family, and initiate further services if they are necessary.
- end of the 6 month period: towards the end of the period, the APN will determine, with the parents and other professionals, if the family needs further support, and which specialist would be most appropriate to continue the collaboration with the family.
The role of the interprofessional team:
Within the new model of transitional care, some interprofessional interventions were augmented or adapted.These will be available to families in the intervention group:
Outpatient care by the neonatologist for families that have difficulty getting to a paediatrician, because they live in a rural area with no paediatrician; Standardized psychological support to re-establish emotional stability, improve the ability of parents to cope with the situation and to prevent parental and family adaptive disorders and child developmental disorders; More frequent and standardized involvement of lactation consultant; Standardized involvement of physiotherapy and social workers; Outpatient music therapy.
The APN will contact and involve other health care professionals, like the family's paediatrician, the outpatient midwife, the community health care nurse or the mother and father counselling as soon as need becomes evident. The APN will help set up meetings between health care professionals and the family, and will keep them up-to-date on the family's situation..
Interprofessional roundtable meetings with health care professionals involved in the care of a specific family will be held every two weeks. The meeting is aimed at developing consensus on the best possible support in the care of preterm infants and their families. Parents will be invited to participate in these meetings.
- Conditions
- Preterm Birth
- Being tested
- neonatologists, psychological support, lactation consultant, physiotherapeutic interventions, social workers
- Keywords
- preterm infants, transition to home, advanced practice nurse, cost-analysis
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neonatologistsBehavioural
will continue to be contact persons for the APN, even after hospital discharge, and will be available for 3 fixed outpatient consultations with the APN and families that have difficulty getting to a paediatrician, because they live in a rural area with no paediatrician.
psychological supportBehavioural
Psychological support will be standard for all families. In a first consultation, psychologist and family will decide about long-term psychological support. They will have at least 3 follow-up consultations during hospital stay and one before discharge; specific psychological interventions will be provided. The aim of the interventions is to re-establish emotional stability and improve the ability of parents to cope with the situation, to prevent parental and family adaptive disorders and child developmental disorders. Support focus on screening for psychological disorders. Techniques include family-centred, holistic interventions (e.g. activating parental resources and coping, crisis intervention, stabilization techniques etc.). Parents will receive outpatient psychological support.
lactation consultantBehavioural
during hospitalization, the lactation consultant will be involved more frequently than during standard care. Breastfeeding support will take a structured approach and will be performed in close collaboration with both parents. The main aims of structured breastfeeding support are strengthen parent-child bonding. Infants will be breastfed according to their needs. Parents will become competent in meeting their child's nutritional needs. After discharge, parents may schedule outpatient breastfeeding consultations.
physiotherapeutic interventionsBehavioural
physiotherapeutic interventions will also be structured. The physiotherapist will make an assessment during hospitalization, and decide which physiotherapeutic interventions are necessary. Each family will learn how to handle their premature child in everyday life, based on the child's developmental stage, in a single consultation.
social workersBehavioural
social workers will closely collaborate with the APN within the transitional model. They will be involved with every family and will assist the APN in establishing a network with social and medical services within and outside the clinic. They will also support families in coping with daily life and with their integration into society, family and work. Furthermore, they will give advice on social security issues and on asserting claims as well as clarify financial possibilities.
music therapyBehavioural
music therapy with premature infants and their parents creates a new dimension of contact, and helps stabilize the child and supports their development through music. It also reduces the anxiety of parents, and enhances self-efficacy and makes them more sensitive to their child 74,75, thus enhancing the parent-child relationship. In standard care, music therapy is offered only during hospitalization. In the new model of care, after NICU discharge, the program will offer 10 follow-up sessions at the family's home or in the music therapists' private practice.
other health care professionalsBehavioural
the APN will contact and involve other health care professionals, like the family's paediatrician, the outpatient midwife, the community health care nurse or the mother and father counselling as soon as need becomes evident. The APN will help set up meetings between health care professionals and the family, and will keep them up-to-date on the family's situation.
interprofessional roundtable meetingsBehavioural
interprofessional roundtable meetings with health care professionals involved in the care of a specific family will be held every two weeks. The meeting is aimed at developing consensus on the best possible support in the care of preterm infants and their families. Parents will be invited to participate in these meetings, led by the APN. The meeting will focus on two family situations, and then determine and initiate supportive interventions in collaboration with the parents.
Advanced practice nurses' interventionsBehavioural
The APN will participate in comprehensively planning individual discharge, coordinating services, consulting with other healthcare professionals, assessing needs on a case by case basis, and coaching the family from birth to 6 months after discharge from the NICU. The APN will provide the Newborn Behavioral Observation (NBO), an infant-centred and family-focused method for building relationships, to parents and children, during and after hospitalization. The NBO helps sensitize parents to their infant's competencies and capabilities, teaching them to read their infant's signals and understand their behaviours. It promotes positive interactions between parent and preterm infant. The APN will also offer telephone support and follow-up Visits at home after discharge.
| Study group | Role | What they receive |
|---|---|---|
| APN-led Intervention | Experimental | Intervention group being provided with the interventions described below.
* Advanced practice nurses' interventions
* Neonatologists: neonatal outpatient consultation
* psychological support
* lactation consultant
* physiotherapeutic interventions
* collaboration with social workers
* music therapy
* close collaboration with other health care professionals
* interprofessional roundtable meetings Receives: Behavioral: neonatologists; Behavioral: psychological support; Behavioral: lactation consultant; Behavioral: physiotherapeutic interventions; Behavioral: social workers; Behavioral: music therapy; Behavioral: other health care professionals; Behavioral: interprofessional roundtable meetings; Behavioral: Advanced practice nurses' interventions |
| Control, Standard Care | No intervention | Control group receiving standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent-child interaction
Parent-child interaction is assessed with the CARE-Index. Three-minute video recordings made in the home setting will be coded by a certified blinded independent coder. The coding procedure focuses on seven aspects of adult and infant behavior. Each aspect of behavior is evaluated separately, for adult and infant, then the scores are summed to generate seven scale scores. For the adult, these are sensitivity, control, and unresponsiveness. For infants they are cooperativeness, compulsiveness, difficultness, and passivity.
The scores on these scales range from 0-14, with zero sensitivity being dangerously insensitive, 7 being normally sensitive, and 14 being outstandingly sensitive. On the adult sensitivity scale, scores of 5-6 suggest the need for parental education, 3-4 suggests the need for parenting intervention, and 0-2 suggests the need for psychotherapy for the parent.
Measured: Once 6 month after discharge
Parent depressive symptoms
Depressive symptoms will be assessed with the short version of the 'Allgemeine Depressionsskala' (ADS-K), rated on a 4-point Likert-type scale. The sum score is dichotomized for binary analyses.
Measured: From birth until 6 months after discharge (at 5 time points)
Parent anxiety
Parental anxiety will be assessed with State-Trait Anxiety Inventory (STAI), to measure State Anxiety, and Trait Anxiety. Responses are scored on 4-point forced-choice Likert-type scales.
Measured: From birth until 6 months after discharge (at 5 time points)
Parent Posttraumatic Stress Disorder
PTSD-Checklist (PCL-5) is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms over the past month. Items are rated on a 5-point Likert Scale ranging from 0 (not at all) - 4 (extremely). Items are summed to provide a total severity score (range = 0-80). At total score of 33 or higher indicates the presence of a posttraumatic stress disorder.
Measured: From birth until 6 months after discharge (at 5 time points)
Parenting stress
Parenting stress will be measured with the Parenting Stress Index Short Form (PSI-SF), a self-reporting questionnaire that contains 36 items rated on a 5-point Likert Scale (strongly agree to strongly disagree). Overall parenting stress is indicated by the total stress score. Parents report their level of agreement with 36 items that fall into three subscales (12 items each subscale): Parental distress, parent-child dysfunctional interaction and difficult child. The PSI-SF includes a defensive responding scale (seven items from the Parental Distress scale) that indicates the degree to which the parent might be attempting to deny or minimize problems.
The raw scores will need to be converted into percentile scores. For each sub-scale a score which falls between the 15th and 80th percentile is considered typical. High scores are those at or above the 85th percentile considering high parenting stress.
Measured: From birth until 6 months after discharge (at 5 time points)
Parent self-efficacy
Tool to measure parenting self-efficacy (TOPSE) is an instrument of 48 statements that encompasses eight dimensions of parenting. The german version of the TOPSE, was reduced to 30 items that encompass five dimensions of parenting (emotion and affection, empathy and understanding, pressures, self-acceptance and learning and knowledge). The items are rated on an 11-point Likert scale.
Measured: From birth until 6 months after discharge (at 5 time points)
Infant growth status
Growth Status including weight in kg, height in cm and head circumference in cm will be continuously assessed from medical records.
Measured: From birth until 6 months after discharge
Infant behaviour
Infant temperament, behaviour and self-regulation abilities will be measured used the Infant Behavior Questionnaire-Revised (IBQ-R) short-form at the end of the 6-month study period. IBQ-R consists of 91 items that span 14 scales (Activity Level, Approach, Cuddliness, Distress to Limitations, Duration of Orienting, Falling Reactivity, Fear, High Intensity Pleasure, Low Intensity Pleasure, Perceptual Sensitivity, Sadness, Smiling and Laughter, Soothability and Vocal Reactivity).
Measured: Once 6 month after discharge
Quality of life
Quality of life will be assessed with the Visual Analog Scale (VAS). Parents will mark a spot along a line from 1 indicating worst possible quality of life to 10 indicating best possible quality of life.
Measured: From birth until 6 months after discharge (at 3 time points)
Study burden
Will be evaluated at the end of the study period with a Visual Analog Scale (VAS). Parents will mark a spot along a line from 0 indicating no study burden to 10 indicating highest possible study burden. The VAS will be part of the 6-month questionnaire.
Measured: Once 6 month after discharge
Sleep patterns
Sleep patterns will be continuously assessed from medical records.
Measured: From birth until 6 months after discharge
Self-regulation abilities
Self-regulation abilities will be continuously assessed from medical records.
Measured: From birth until 6 months after discharge
Secondary outcomes (3)
Model evaluation
Duration, content, and type of contact with all involved healthcare professionals will be documented continuously from hospital and APN records. These will include telephone consultations, home visits and office and hospital visits (including visits to the emergency department). Data will be entered into an Excel sheet for each family.
Measured: 6 Month
Cost analysis
Financial data will be collected for costs incurred during hospital stay as well as post hospital discharge. For the duration of hospital stay the investigators will extract data on length of hospital stay, readmission rates, reason and length of re-hospitalization and all the arising costs from the hospital records. For post-discharge costs, data will be extracted from invoices to patients and a simple questionnaire. The investigators will base cost-effectiveness analyses and cost results on different metrics of outcome measures (Depressive Symptoms, Anxiety, Post-traumatic stress disorders, Parent Child Interaction, Perceived Self-efficacy, etc.).
Measured: 6 Month
Infant Nutrition Management and feeding behaviour
Infant Nutrition Management including description of what kind of Nutrition the child is getting, in which way the child get's the Nutrition (e.g. breastfeeding) and the nutritional challenges parents are confronted with will be continuously assessed from medical records.
Measured: From birth until 6 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start1 Feb 2018
- Primary completion30 Apr 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An advanced practice nurse (APN)-led Intervention which focuses on improving parental mental health and well-being, on infant growth and development and on lowering overall costs.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Bern University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Mathias Nelle, PD, Principal investigator, Insel Gruppe AG, University Hospital BernEva Cignacco, PD, Principal investigator, Bern University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460496
- Sponsor's protocol ID
- 2017-01249
- Other IDs
- 2017
- Status last verified
- Apr 2019
- First submitted
- 23 Jan 2018
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators are willing to share IPD but there is no plan description yet available. The investigators will discuss how to develop a plan and the implementation in the upcoming future.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transition to Home (TtH) After Preterm Birth: Pilot Testing an Advanced Practice Nurse (APN)-Led Model of Transitional Care
- ClinicalTrials.gov ID
- NCT03460496
- Acronym / sponsor ID
- 2017-01249
- Conditions
- Preterm Birth
- Keywords
- preterm infants, transition to home, advanced practice nurse, cost-analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Bern University of Applied Sciences
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preterm birth is associated with significant and often life-long developmental, emotional and financial burdens. Preterm infants face several challenges that continue late into life, including developmental delays, social, and behavioural problems and poor academic performance. Parents also suffer considerable emotional and physical stress which in turn can have a negative impact on the child's development.
In Switzerland, during the transition from hospital to home, there are not many interventions intended to improve mental health outcomes in parents or to promote positive parenting to improve developmental outcomes for the preterm infant. There are also few interventions to reduce associated health care costs.
In order to improve parent and preterm infant outcomes, reduce hospital stay in the neonatal intensive care unit (NICU), lower readmission rates, and avoid unnecessary use of primary care resources a unique, new model of transitional care was developed. The new 'Transition to Home' (TtH) model makes use of well-tested, successful methods of post-discharge care.
The investigators' study will evaluate the organizational and financial feasibility and cost effectiveness of the TtH model for infants born preterm by measuring the impact of an Advanced Practice Nurse (APN)-led intervention at the Children's University Hospital Bern. The intervention focuses on improving parental mental health and well-being, on infant growth and development, and on lowering overall costs. The investigators will gather data and then adapt and test the model within a longitudinal interventional comparative effectiveness study, and prepare it for other Cantons in Switzerland to implement.
Detailed description
In The investigators' model, the APN will participate in comprehensively planning individual discharge, coordinating services, consulting with other healthcare professionals, assessing needs on a case by case basis, and coaching the family from birth to 6 months after discharge from the NICU. The APN will be supported by specialized neonatology nurses; together, they will form the Advanced Nursing Practice Team (ANP Team). Currently, 4 APNs are in training for the project.
The most important tasks of the APN are listed below:
- at birth and during initial hospitalization: first contact of the APN with the family, followed by regular visits, consultations, and educational training for and coordination with other services like lactation consultant, psychologist, social support etc. The APN will conduct family interviews at regular intervals, consult with and train parents on predefined topics in a structured manner while closely collaborating with nursing and medical staff. The APN will take a family-centred approach to making joint decisions. The APN will coordinate health care providers, encourage information flow and collaboration between the professionals as well as organize and manage regular interprofessional exchanges.
- discharge from the hospital: the APN will plan the comprehensive discharge together with parents and the interprofessional team.
- at home: the APN will make systematic follow-up after discharge. The APN will also offer telephone support for requests and answer parent's questions. They will also make follow-up home visits to assess the situation, including assessing physical and mental well-being of parents and infants. The APN will evaluate the interventions the family requested, discuss them with the family, and initiate further services if they are necessary.
- end of the 6 month period: towards the end of the period, the APN will determine, with the parents and other professionals, if the family needs further support, and which specialist would be most appropriate to continue the collaboration with the family.
The role of the interprofessional team:
Within the new model of transitional care, some interprofessional interventions were augmented or adapted.These will be available to families in the intervention group:
Outpatient care by the neonatologist for families that have difficulty getting to a paediatrician, because they live in a rural area with no paediatrician; Standardized psychological support to re-establish emotional stability, improve the ability of parents to cope with the situation and to prevent parental and family adaptive disorders and child developmental disorders; More frequent and standardized involvement of lactation consultant; Standardized involvement of physiotherapy and social workers; Outpatient music therapy.
The APN will contact and involve other health care professionals, like the family's paediatrician, the outpatient midwife, the community health care nurse or the mother and father counselling as soon as need becomes evident. The APN will help set up meetings between health care professionals and the family, and will keep them up-to-date on the family's situation..
Interprofessional roundtable meetings with health care professionals involved in the care of a specific family will be held every two weeks. The meeting is aimed at developing consensus on the best possible support in the care of preterm infants and their families. Parents will be invited to participate in these meetings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An advanced practice nurse (APN)-led Intervention which focuses on improving parental mental health and well-being, on infant growth and development and on lowering overall costs.
| Arm | Type | Receives |
|---|---|---|
| APN-led Intervention | Experimental | Behavioral: neonatologists, Behavioral: psychological support, Behavioral: lactation consultant, Behavioral: physiotherapeutic interventions, Behavioral: social workers, Behavioral: music therapy, Behavioral: other health care professionals, Behavioral: interprofessional roundtable meetings, Behavioral: Advanced practice nurses' interventionsIntervention group being provided with the interventions described below. * Advanced practice nurses' interventions * Neonatologists: neonatal outpatient consultation * psychological support * lactation consultant * physiotherapeutic interventions * collaboration with social workers * music therapy * close collaboration with other health care professionals * interprofessional roundtable meetings |
| Control, Standard Care | No intervention | –Control group receiving standard care |
Who may qualify
- Ages
- 24 to 35 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Families of preterm infants (between 24 0/7 weeks and 34 6/7 weeks of gestation) born and hospitalized in the University Hospital Bern
- Infants will need to be discharged directly from the Neonatology department, and their parents must reside in Canton Bern, and speak German, French or English.
- For multiple births, all infants will be followed.
- Written informed consent by the parents
Key exclusion criteria (1 listed)
- Preterm infants with congenital heart malformations and other congenital problems evident at birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neonatologistswill continue to be contact persons for the APN, even after hospital discharge, and will be available for 3 fixed outpatient consultations with the APN and families that have difficulty getting to a paediatrician, because they live in a rural area with no paediatrician. | Behavioural | APN-led Intervention |
| psychological supportPsychological support will be standard for all families. In a first consultation, psychologist and family will decide about long-term psychological support. They will have at least 3 follow-up consultations during hospital stay and one before discharge; specific psychological interventions will be provided. The aim of the interventions is to re-establish emotional stability and improve the ability of parents to cope with the situation, to prevent parental and family adaptive disorders and child developmental disorders. Support focus on screening for psychological disorders. Techniques include family-centred, holistic interventions (e.g. activating parental resources and coping, crisis intervention, stabilization techniques etc.). Parents will receive outpatient psychological support. | Behavioural | APN-led Intervention |
| lactation consultantduring hospitalization, the lactation consultant will be involved more frequently than during standard care. Breastfeeding support will take a structured approach and will be performed in close collaboration with both parents. The main aims of structured breastfeeding support are strengthen parent-child bonding. Infants will be breastfed according to their needs. Parents will become competent in meeting their child's nutritional needs. After discharge, parents may schedule outpatient breastfeeding consultations. | Behavioural | APN-led Intervention |
| physiotherapeutic interventionsphysiotherapeutic interventions will also be structured. The physiotherapist will make an assessment during hospitalization, and decide which physiotherapeutic interventions are necessary. Each family will learn how to handle their premature child in everyday life, based on the child's developmental stage, in a single consultation. | Behavioural | APN-led Intervention |
| social workerssocial workers will closely collaborate with the APN within the transitional model. They will be involved with every family and will assist the APN in establishing a network with social and medical services within and outside the clinic. They will also support families in coping with daily life and with their integration into society, family and work. Furthermore, they will give advice on social security issues and on asserting claims as well as clarify financial possibilities. | Behavioural | APN-led Intervention |
| music therapymusic therapy with premature infants and their parents creates a new dimension of contact, and helps stabilize the child and supports their development through music. It also reduces the anxiety of parents, and enhances self-efficacy and makes them more sensitive to their child 74,75, thus enhancing the parent-child relationship. In standard care, music therapy is offered only during hospitalization. In the new model of care, after NICU discharge, the program will offer 10 follow-up sessions at the family's home or in the music therapists' private practice. | Behavioural | APN-led Intervention |
| other health care professionalsthe APN will contact and involve other health care professionals, like the family's paediatrician, the outpatient midwife, the community health care nurse or the mother and father counselling as soon as need becomes evident. The APN will help set up meetings between health care professionals and the family, and will keep them up-to-date on the family's situation. | Behavioural | APN-led Intervention |
| interprofessional roundtable meetingsinterprofessional roundtable meetings with health care professionals involved in the care of a specific family will be held every two weeks. The meeting is aimed at developing consensus on the best possible support in the care of preterm infants and their families. Parents will be invited to participate in these meetings, led by the APN. The meeting will focus on two family situations, and then determine and initiate supportive interventions in collaboration with the parents. | Behavioural | APN-led Intervention |
| Advanced practice nurses' interventionsThe APN will participate in comprehensively planning individual discharge, coordinating services, consulting with other healthcare professionals, assessing needs on a case by case basis, and coaching the family from birth to 6 months after discharge from the NICU. The APN will provide the Newborn Behavioral Observation (NBO), an infant-centred and family-focused method for building relationships, to parents and children, during and after hospitalization. The NBO helps sensitize parents to their infant's competencies and capabilities, teaching them to read their infant's signals and understand their behaviours. It promotes positive interactions between parent and preterm infant. The APN will also offer telephone support and follow-up Visits at home after discharge. | Behavioural | APN-led Intervention |
Primary outcome
Parent-child interaction
Time frame: Once 6 month after discharge
Parent-child interaction is assessed with the CARE-Index. Three-minute video recordings made in the home setting will be coded by a certified blinded independent coder. The coding procedure focuses on seven aspects of adult and infant behavior. Each aspect of behavior is evaluated separately, for adult and infant, then the scores are summed to generate seven scale scores. For the adult, these are sensitivity, control, and unresponsiveness. For infants they are cooperativeness, compulsiveness, difficultness, and passivity. The scores on these scales range from 0-14, with zero sensitivity being dangerously insensitive, 7 being normally sensitive, and 14 being outstandingly sensitive. On the adult sensitivity scale, scores of 5-6 suggest the need for parental education, 3-4 suggests the need for parenting intervention, and 0-2 suggests the need for psychotherapy for the parent.
Parent depressive symptoms
Time frame: From birth until 6 months after discharge (at 5 time points)
Depressive symptoms will be assessed with the short version of the 'Allgemeine Depressionsskala' (ADS-K), rated on a 4-point Likert-type scale. The sum score is dichotomized for binary analyses.
Parent anxiety
Time frame: From birth until 6 months after discharge (at 5 time points)
Parental anxiety will be assessed with State-Trait Anxiety Inventory (STAI), to measure State Anxiety, and Trait Anxiety. Responses are scored on 4-point forced-choice Likert-type scales.
Parent Posttraumatic Stress Disorder
Time frame: From birth until 6 months after discharge (at 5 time points)
PTSD-Checklist (PCL-5) is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms over the past month. Items are rated on a 5-point Likert Scale ranging from 0 (not at all) - 4 (extremely). Items are summed to provide a total severity score (range = 0-80). At total score of 33 or higher indicates the presence of a posttraumatic stress disorder.
Parenting stress
Time frame: From birth until 6 months after discharge (at 5 time points)
Parenting stress will be measured with the Parenting Stress Index Short Form (PSI-SF), a self-reporting questionnaire that contains 36 items rated on a 5-point Likert Scale (strongly agree to strongly disagree). Overall parenting stress is indicated by the total stress score. Parents report their level of agreement with 36 items that fall into three subscales (12 items each subscale): Parental distress, parent-child dysfunctional interaction and difficult child. The PSI-SF includes a defensive responding scale (seven items from the Parental Distress scale) that indicates the degree to which the parent might be attempting to deny or minimize problems. The raw scores will need to be converted into percentile scores. For each sub-scale a score which falls between the 15th and 80th percentile is considered typical. High scores are those at or above the 85th percentile considering high parenting stress.
Parent self-efficacy
Time frame: From birth until 6 months after discharge (at 5 time points)
Tool to measure parenting self-efficacy (TOPSE) is an instrument of 48 statements that encompasses eight dimensions of parenting. The german version of the TOPSE, was reduced to 30 items that encompass five dimensions of parenting (emotion and affection, empathy and understanding, pressures, self-acceptance and learning and knowledge). The items are rated on an 11-point Likert scale.
Infant growth status
Time frame: From birth until 6 months after discharge
Growth Status including weight in kg, height in cm and head circumference in cm will be continuously assessed from medical records.
Infant behaviour
Time frame: Once 6 month after discharge
Infant temperament, behaviour and self-regulation abilities will be measured used the Infant Behavior Questionnaire-Revised (IBQ-R) short-form at the end of the 6-month study period. IBQ-R consists of 91 items that span 14 scales (Activity Level, Approach, Cuddliness, Distress to Limitations, Duration of Orienting, Falling Reactivity, Fear, High Intensity Pleasure, Low Intensity Pleasure, Perceptual Sensitivity, Sadness, Smiling and Laughter, Soothability and Vocal Reactivity).
Quality of life
Time frame: From birth until 6 months after discharge (at 3 time points)
Quality of life will be assessed with the Visual Analog Scale (VAS). Parents will mark a spot along a line from 1 indicating worst possible quality of life to 10 indicating best possible quality of life.
Study burden
Time frame: Once 6 month after discharge
Will be evaluated at the end of the study period with a Visual Analog Scale (VAS). Parents will mark a spot along a line from 0 indicating no study burden to 10 indicating highest possible study burden. The VAS will be part of the 6-month questionnaire.
Sleep patterns
Time frame: From birth until 6 months after discharge
Sleep patterns will be continuously assessed from medical records.
Self-regulation abilities
Time frame: From birth until 6 months after discharge
Self-regulation abilities will be continuously assessed from medical records.
3 secondary outcomes
Model evaluation
Time frame: 6 Month
Cost analysis
Time frame: 6 Month
Infant Nutrition Management and feeding behaviour
Time frame: From birth until 6 months after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Individual participant dataSharing planned: Undecided. The investigators are willing to share IPD but there is no plan description yet available. The investigators will discuss how to develop a plan and the implementation in the upcoming future.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathias Nelle, PD principal investigator
Insel Gruppe AG, University Hospital Bern
Eva Cignacco, PD principal investigator
Bern University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neonatologists, psychological support and lactation consultant in people with Preterm Birth, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natascha Schuetz Haemmerli, MScN (+41 31 848 47 13, natascha.schuetzhaemmerli@bfh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent-child interaction (time frame: Once 6 month after discharge). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.