Parent-Child RelationsVVME5NCT04635150
National Evaluation of the Close Collaboration With Parents Training
A study testing Close Collaboration with Parents in people with Parent-Child Relations and Parenting, run by Turku University Hospital.
Trial summary
The aim of this study was to evaluate the effects of an educational intervention for neonatal staff on parent-infant physical closeness during their infant's stay in the Neonatal Intensive Care Unit (NICU) and parents' and staff perception on family centered care in the unit. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relations, Parenting, Infant, Newborn, Disease
- What is being tested?
- Close Collaboration with Parents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 768 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2012to 30 Sep 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Every parent of an infant estimated to stay in the NICU longer than three days was approached.
Who cannot join
- Infant had major congenital anomalies or syndromes,
- Parents spoke neither Finnish or Swedish,
- Family lived outside the catchment area of the hospital.
- All staff members working at bedside and leadership.
About this study
Official title: National Evaluation of the Close Collaboration With Parents Training. Enhancing Parents' Presence and Participation During Neonatal Intensive Care.
The aim of this study was to evaluate the effects of an educational intervention for neonatal staff on parent-infant physical closeness during their infant's stay in the Neonatal Intensive Care Unit (NICU) and parents' and staff perception on family centered care in the unit. This pre-post intervention study was carried out in nine hospitals in Finland in 2012 through 2018. Data was collected by using daily parental diaries, daily text message questions to parents and an audit interview for the staff.
Read the detailed description
The aim of this study was to evaluate the effects of an educational intervention for neonatal staff on parent-infant physical closeness during their infant's stay in the Neonatal Intensive Care Unit (NICU) and parents' and staff perception on family centered care (FCC) in the unit. We hypothesized that parents spend more time in the unit and have more skin-to skin contact with their infant after the intervention compared to the time before the intervention. We also hypothesized that care culture becomes more family centered after the intervention both from parent and staff perspectives.
Study NICUs and participants This study was an intervention study, comparing the situation before and after the intervention. It was carried out in nine NICUs in Finland, including two level III hospitals and seven level II hospitals. The study progressed stepwise between May 2012 and September 2018; two or three hospitals participated in the study simultaneously. The study permission was granted by the Hospital District of Southwest Finland (T57/2012) and separately by each study site.
The study participants were recruited during three-month periods before and after the Close Collaboration with Parents training program, which lasted for 18 months. Every parent of an infant estimated to stay in the NICU longer than three days was approached. Other inclusion criteria were: 1) the infant had no major congenital anomalies or syndromes, 2) the parents spoke Finnish or Swedish, 3) the family lived in the catchment area of the hospital. A log including infant's gestational age, birth weight, the length of hospital period and the distance to home was kept for all admissions of infants with a length of stay longer than 3 days to identify eligible parents and evaluate drop-out rate.
The staff introduced the study protocol to parents and gave them at least one day to consider their participation. After the parents signed the informed consent form, they were given instructions for use of the closeness diaries and text messages. The parents provided infant characteristics (including gestational age, birthweight, birth head circumference, sex, mode of delivery, and whether the infant was a singleton/multiple or had siblings) and family characteristics (including parents' age, education, socio-economic status and the distance from the hospital to home).
Closeness diary The duration of parents' presence in the NICU and skin-to-skin contact (SSC) was reported with closeness diaries. Presence in the unit was defined by being inside the unit, not necessarily all the time in the room of the baby. SSC was defined as the baby lying on the parent's bare chest dressed only in a diaper and a cap if necessary. On the diary, there were four different timelines where parents filled in the time spent in NICU and SSC with their infant: mother present, mother SSC, father present, and father SSC. Parents were asked to fill in the diaries from the time of recruitment until discharge. During data collection, the diaries were stored in a folder at the bedside so that other families or nurses did not see the diaries.
Intervention The Close Collaboration with Parents intervention was developed based on theoretical evidence from infant neurobehavioral and attachment theories. The training is based on a multi-method learning philosophy using theoretical teaching, hands-on teaching at bedside, and reflective discussions supporting simultaneous implementation of practice change. The intervention teaches new skills to the entire staff of a unit to collaborate with parents in order to support parents' presence and involvement in infant's care. The original intervention was condensed to a structured 18-month-long training including four phases. A facilitator network model was used including local mentors trained by the trainer mentors and a supervisor.
BLISS Audit tool The data from staff were collected using the Bliss Baby Charter Audit Tool with permission of Bliss organization. The audit tool is a self-assessment instrument identifying areas of improvement in the quality of FCC in NICUs. The tool has 141 statements divided into seven core principles which summarize the care, respect and support that infants and their parents should receive. All seven principles contain different categories of family-centered care (as defined by Bliss). The categories are 1) Active care by parent and staff, (18 criteria), 2) Parent and family support (17 criteria), 3) Communication (6 criteria), 4) Developmental care (9 criteria), 5) Empowered decision making (10 criteria), 6) Facilities (17 criteria) ,7) Guidelines and policies (17 criteria), 8) Staff skills and training (12 criteria), 9) Information provision (27 criteria) and 10) Service improvement and parent involvement (8 criteria).
DigiFCC Parents evaluated the quality of FCC with DigiFCC-P tool by answering to the text-message questions delivered by mobile phones. The tool was developed for the evaluation of the Close Collaboration with Parents training Program. Parents received one randomized question from seven questions every evening during their infant hospitalization. The tool was further developed based on feedback from parents, staff, and researchers to improve its content validity and feasibility after the first four hospitals. In hospitals 5 to 9, parents received one randomized question from nine questions every evening during their infant hospitalization. The questions were: 1) To what extent did the staff listen to you today? 2) To what extent did you participate in your baby's care today? 3) To what extent did the guidance provided by the staff meet your needs today? 4) To what extent was your opinion considered in decisions made about your baby today? 5) To what extent did you trust the staff in the care of your baby today? 6) To what extent did the staff trust you in the care of your baby today? 7) To what extent did you participate in the discussion during the medical round? 8) To what extent did the information provided by the staff meet your needs today? 9) To what extent did the staff offer you emotional support today? Parents rated their responses on a 5-point Likert scale in hospitals 1 to 4, and in a 7-point Likert scale in hospitals 5 to 9 (1-7, with 1= not at all, 7= very much) or 0, if they were not in the NICU that day.
Nurses evaluated the quality of FCC with the DigiFCC-N tool. Nurses answered corresponding questions with the parents' questions exception of the question that concerned parental participation in the medical round. Questions to nurses were in a form: "To what extent did you listen to parents today?" Nurses gave the answer through a Web questionnaire using the computer assigned for the research purpose. Nurses replied one randomized question after each work shift during a 3-months study period before and after the training program.
Statistical methods Parents' presence was defined as at least one parent present. Mothers' and fathers' presence and SSC were also analysed separately. We compared the pre-intervention and post-intervention cohorts adjusting for gestational age, siblings in the family, and the neonatal unit in the statistical model. These confounders were chosen based their significance on parents' presence. The comparison of presence and SSC was analyzed using a linear model, where cohorts were independent families, siblings in the family and neonatal unit were handled as categorical variables, and gestational age as a continuous covariate. Analyses were performed for mother and father separately and then also as combined (at least one parent present, either parent SSC). All diaries until the last one were included in the analyses, also the days without presence or SSC or missing data. All statistical tests were performed as two-sided, with a significance level set at 0.05. The analyses were performed using SAS System, version 9.4 for Windows (SAS Institute Inc., Cary, NC, USA).
- Conditions
- Parent-Child Relations, Parenting, Infant, Newborn, Disease
- Being tested
- Close Collaboration with Parents
- Keywords
- NICU, Family centered care, Parent-infant closeness, Skin-to-skin
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Close Collaboration with ParentsBehavioural
Close Collaboration with Parents Training Program is an educational intervention for multidisciplinary NICU staff initially developed and implemented at Turku University Hospital to promote FCC. The intervention consists of four phases lasting 4 to 5 months each. First the healthcare staff learn to observe infant behavior. This phase aims at identifying the individual needs and features of each infant. After that, the staff observe infant behavior with the parents and learn to actively listen to parents' perceptions about their infant. During the phase III, staff learn to know the individual story of the family and their infant, which supports partnership between staff and parents. Finally, staff learn to integrate parents in decision-making and collaboratively plan the transition to home. The training is delivered through facilitator-network model in which local mentors are trained by the trainer mentors and supervisors.
| Study group | Role | What they receive |
|---|---|---|
| Post-intervention parents and staff | Experimental | An educational intervention for the multidisciplinary staff of a neonatal intensive care unit. Receives: Behavioral: Close Collaboration with Parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Closeness Diary of parents' presence
Daily Closeness Diary including space for both mothers and fathers to indicate their presence in the neonatal unit (minutes/per day in 5-minute accuracy) to be filled in during all hospital days of the infant (up to 3 months).
Measured: During the time the infant was cared for in the neonatal unit (up to 3 months), applicable to both cohorts of infants: those recruited before and after the intervention.
Parental Closeness Diary of parent-infant skin-to-skin contact
Daily Closeness Diary including space for both mothers and fathers to indicate skin-to-skin contact with their infant (minutes/per day in 5-minute accuracy) to be filled in during all hospital days of the infant (up to 3 months). Skin-to-skin contact is defined as the infant is lying naked on a parent's chest.
Measured: During the time the infant was cared for in the neonatal unit (up to 3 months), applicable to both cohorts of infants: those recruited before and after the intervention. .
Daily text message questions to both mothers and fathers/partners about parents' satisfaction to family centered care
Both parents received one question (randomly out of 9 questions) every evening at 9 pm to report their satisfaction about the specific issue during that day.
Measured: During the time the infant was cared for in the neonatal unit (up to 3 months), applicable to both cohorts of infants: those recruited before and after the intervention.
Web questions for the staff about the quality of family centered care they have provided during their work shift
Each staff member responded to one web question (randomly out of 8 questions) after each workshift about the quality of family centered care they had provided that day.
Measured: Three months before and three months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start30 May 2012
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post intervention study with different cohorts before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 768 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Turku
- Responsible party
- Principal investigator, Liisa Lehtonen, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635150
- Sponsor's protocol ID
- K37/12
- Acronym
- VVME5
- Status last verified
- Nov 2020
- First submitted
- 12 Nov 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
He FB, Axelin A, Ahlqvist-Bjorkroth S, Raiskila S, Loyttyniemi E, Lehtonen L. Effectiveness of the Close Collaboration with Parents intervention on parent-infant closeness in NICU. BMC Pediatr. 2021 Jan 11;21(1):28. doi: 10.1186/s12887-020-02474-2.
PubMed 33430816
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Evaluation of the Close Collaboration With Parents Training. Enhancing Parents' Presence and Participation During Neonatal Intensive Care.
- ClinicalTrials.gov ID
- NCT04635150
- Acronym / sponsor ID
- VVME5 / K37/12
- Conditions
- Parent-Child Relations, Parenting, Infant, Newborn, Disease
- Keywords
- NICU, Family centered care, Parent-infant closeness, Skin-to-skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 768 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Turku
- Study start
- 30 May 2012 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 18 Nov 2020 (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.
The aim of this study was to evaluate the effects of an educational intervention for neonatal staff on parent-infant physical closeness during their infant's stay in the Neonatal Intensive Care Unit (NICU) and parents' and staff perception on family centered care in the unit. This pre-post intervention study was carried out in nine hospitals in Finland in 2012 through 2018. Data was collected by using daily parental diaries, daily text message questions to parents and an audit interview for the staff.
Detailed description
The aim of this study was to evaluate the effects of an educational intervention for neonatal staff on parent-infant physical closeness during their infant's stay in the Neonatal Intensive Care Unit (NICU) and parents' and staff perception on family centered care (FCC) in the unit. We hypothesized that parents spend more time in the unit and have more skin-to skin contact with their infant after the intervention compared to the time before the intervention. We also hypothesized that care culture becomes more family centered after the intervention both from parent and staff perspectives.
Study NICUs and participants This study was an intervention study, comparing the situation before and after the intervention. It was carried out in nine NICUs in Finland, including two level III hospitals and seven level II hospitals. The study progressed stepwise between May 2012 and September 2018; two or three hospitals participated in the study simultaneously. The study permission was granted by the Hospital District of Southwest Finland (T57/2012) and separately by each study site.
The study participants were recruited during three-month periods before and after the Close Collaboration with Parents training program, which lasted for 18 months. Every parent of an infant estimated to stay in the NICU longer than three days was approached. Other inclusion criteria were: 1) the infant had no major congenital anomalies or syndromes, 2) the parents spoke Finnish or Swedish, 3) the family lived in the catchment area of the hospital. A log including infant's gestational age, birth weight, the length of hospital period and the distance to home was kept for all admissions of infants with a length of stay longer than 3 days to identify eligible parents and evaluate drop-out rate.
The staff introduced the study protocol to parents and gave them at least one day to consider their participation. After the parents signed the informed consent form, they were given instructions for use of the closeness diaries and text messages. The parents provided infant characteristics (including gestational age, birthweight, birth head circumference, sex, mode of delivery, and whether the infant was a singleton/multiple or had siblings) and family characteristics (including parents' age, education, socio-economic status and the distance from the hospital to home).
Closeness diary The duration of parents' presence in the NICU and skin-to-skin contact (SSC) was reported with closeness diaries. Presence in the unit was defined by being inside the unit, not necessarily all the time in the room of the baby. SSC was defined as the baby lying on the parent's bare chest dressed only in a diaper and a cap if necessary. On the diary, there were four different timelines where parents filled in the time spent in NICU and SSC with their infant: mother present, mother SSC, father present, and father SSC. Parents were asked to fill in the diaries from the time of recruitment until discharge. During data collection, the diaries were stored in a folder at the bedside so that other families or nurses did not see the diaries.
Intervention The Close Collaboration with Parents intervention was developed based on theoretical evidence from infant neurobehavioral and attachment theories. The training is based on a multi-method learning philosophy using theoretical teaching, hands-on teaching at bedside, and reflective discussions supporting simultaneous implementation of practice change. The intervention teaches new skills to the entire staff of a unit to collaborate with parents in order to support parents' presence and involvement in infant's care. The original intervention was condensed to a structured 18-month-long training including four phases. A facilitator network model was used including local mentors trained by the trainer mentors and a supervisor.
BLISS Audit tool The data from staff were collected using the Bliss Baby Charter Audit Tool with permission of Bliss organization. The audit tool is a self-assessment instrument identifying areas of improvement in the quality of FCC in NICUs. The tool has 141 statements divided into seven core principles which summarize the care, respect and support that infants and their parents should receive. All seven principles contain different categories of family-centered care (as defined by Bliss). The categories are 1) Active care by parent and staff, (18 criteria), 2) Parent and family support (17 criteria), 3) Communication (6 criteria), 4) Developmental care (9 criteria), 5) Empowered decision making (10 criteria), 6) Facilities (17 criteria) ,7) Guidelines and policies (17 criteria), 8) Staff skills and training (12 criteria), 9) Information provision (27 criteria) and 10) Service improvement and parent involvement (8 criteria).
DigiFCC Parents evaluated the quality of FCC with DigiFCC-P tool by answering to the text-message questions delivered by mobile phones. The tool was developed for the evaluation of the Close Collaboration with Parents training Program. Parents received one randomized question from seven questions every evening during their infant hospitalization. The tool was further developed based on feedback from parents, staff, and researchers to improve its content validity and feasibility after the first four hospitals. In hospitals 5 to 9, parents received one randomized question from nine questions every evening during their infant hospitalization. The questions were: 1) To what extent did the staff listen to you today? 2) To what extent did you participate in your baby's care today? 3) To what extent did the guidance provided by the staff meet your needs today? 4) To what extent was your opinion considered in decisions made about your baby today? 5) To what extent did you trust the staff in the care of your baby today? 6) To what extent did the staff trust you in the care of your baby today? 7) To what extent did you participate in the discussion during the medical round? 8) To what extent did the information provided by the staff meet your needs today? 9) To what extent did the staff offer you emotional support today? Parents rated their responses on a 5-point Likert scale in hospitals 1 to 4, and in a 7-point Likert scale in hospitals 5 to 9 (1-7, with 1= not at all, 7= very much) or 0, if they were not in the NICU that day.
Nurses evaluated the quality of FCC with the DigiFCC-N tool. Nurses answered corresponding questions with the parents' questions exception of the question that concerned parental participation in the medical round. Questions to nurses were in a form: "To what extent did you listen to parents today?" Nurses gave the answer through a Web questionnaire using the computer assigned for the research purpose. Nurses replied one randomized question after each work shift during a 3-months study period before and after the training program.
Statistical methods Parents' presence was defined as at least one parent present. Mothers' and fathers' presence and SSC were also analysed separately. We compared the pre-intervention and post-intervention cohorts adjusting for gestational age, siblings in the family, and the neonatal unit in the statistical model. These confounders were chosen based their significance on parents' presence. The comparison of presence and SSC was analyzed using a linear model, where cohorts were independent families, siblings in the family and neonatal unit were handled as categorical variables, and gestational age as a continuous covariate. Analyses were performed for mother and father separately and then also as combined (at least one parent present, either parent SSC). All diaries until the last one were included in the analyses, also the days without presence or SSC or missing data. All statistical tests were performed as two-sided, with a significance level set at 0.05. The analyses were performed using SAS System, version 9.4 for Windows (SAS Institute Inc., Cary, NC, USA).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post intervention study with different cohorts before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Post-intervention parents and staff | Experimental | Behavioral: Close Collaboration with ParentsAn educational intervention for the multidisciplinary staff of a neonatal intensive care unit. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
Key exclusion criteria (4 listed)
- All staff members working at bedside and leadership.
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 |
|---|---|---|
| Close Collaboration with ParentsClose Collaboration with Parents Training Program is an educational intervention for multidisciplinary NICU staff initially developed and implemented at Turku University Hospital to promote FCC. The intervention consists of four phases lasting 4 to 5 months each. First the healthcare staff learn to observe infant behavior. This phase aims at identifying the individual needs and features of each infant. After that, the staff observe infant behavior with the parents and learn to actively listen to parents' perceptions about their infant. During the phase III, staff learn to know the individual story of the family and their infant, which supports partnership between staff and parents. Finally, staff learn to integrate parents in decision-making and collaboratively plan the transition to home. The training is delivered through facilitator-network model in which local mentors are trained by the trainer mentors and supervisors. | Behavioural | Post-intervention parents and staff |
Primary outcome
Parental Closeness Diary of parents' presence
Time frame: During the time the infant was cared for in the neonatal unit (up to 3 months), applicable to both cohorts of infants: those recruited before and after the intervention.
Daily Closeness Diary including space for both mothers and fathers to indicate their presence in the neonatal unit (minutes/per day in 5-minute accuracy) to be filled in during all hospital days of the infant (up to 3 months).
Parental Closeness Diary of parent-infant skin-to-skin contact
Time frame: During the time the infant was cared for in the neonatal unit (up to 3 months), applicable to both cohorts of infants: those recruited before and after the intervention. .
Daily Closeness Diary including space for both mothers and fathers to indicate skin-to-skin contact with their infant (minutes/per day in 5-minute accuracy) to be filled in during all hospital days of the infant (up to 3 months). Skin-to-skin contact is defined as the infant is lying naked on a parent's chest.
Daily text message questions to both mothers and fathers/partners about parents' satisfaction to family centered care
Time frame: During the time the infant was cared for in the neonatal unit (up to 3 months), applicable to both cohorts of infants: those recruited before and after the intervention.
Both parents received one question (randomly out of 9 questions) every evening at 9 pm to report their satisfaction about the specific issue during that day.
Web questions for the staff about the quality of family centered care they have provided during their work shift
Time frame: Three months before and three months after the intervention.
Each staff member responded to one web question (randomly out of 8 questions) after each workshift about the quality of family centered care they had provided that day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Derived from this study: PubMed 33430816He FB, Axelin A, Ahlqvist-Bjorkroth S, Raiskila S, Loyttyniemi E, Lehtonen L. Effectiveness of the Close Collaboration with Parents intervention on parent-infant closeness in NICU. BMC Pediatr. 2021 Jan 11;21(1):28. doi: 10.1186/s12887-020-02474-2.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Close Collaboration with Parents in people with Parent-Child Relations and Parenting, run by Turku University Hospital.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Closeness Diary of parents' presence (time frame: During the time the infant was cared for in the neonatal unit (up to 3 months), applicable to both cohorts of infants: those recruited before and after the intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04635150, which also lists 1 linked publication.
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 18 Nov 2020.