PrematureneoPARTNERNCT05343403
Parental Participation on the Neonatal Ward - the neoPARTNER Study
An observational study of Premature and Premature Birth, run by Onze Lieve Vrouwe Gasthuis at 10 sites in Netherlands.
Trial summary
Objective: To investigate the effect of FCR as part of the FICare principles during hospital stay, on parental stress at discharge in parents of preterm or ill infants admitted to the neonatal ward for >7 days as compared to standard medical rounds (SMR) without parents as part of standard neonatal care (SNC). Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Premature, Premature Birth, Prematurity
- What is being tested?
- Family Integrated Care
- How many people
- 613 participants
- Where
- 10 sitesNetherlands
- Study dates
- 7 Mar 2022to 1 Mar 2025
- Phase
- Observational
- 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 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A total of 600 preterm or ill infants, admitted 37 days to a level 2 neonatal ward, with their parents (600 mothers and 600 fathers/partners) will be included in this study. Moreover, healthcare professionals working at the different hospitals will be included as well.
Who may be able to join
- Infant requiring hospital admission directly (within 24 hours) after birth;
- Parent of 18 years or older;
- Written informed consent of both parents.
Who cannot join
- Infant's hospital stay shorter than 7 days;
- Infant with severe congenital or syndromal anomaly;
- Infant with critical illness who is unlikely to survive;
- Parent with current psychosocial problems (such as posttraumatic stress disorder, schizophrenia or psychotic disorders) with or without medication which have not been stable over the past year;
- Involvement of child protective services in the family;
- Parent not able or not willing to fill out questionnaires in English or Dutch.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Netherlands10 sites
Noordwest Ziekenhuisgroep
Alkmaar, North Holland, 1815JD
Flevoziekenhuis
Almere Stad, Flevoland, 1315RA
Ziekenhuis Amstelland
Amstelveen, North Holland, 1186AM
BovenIJ Ziekenhuis
Amsterdam, North Holland, 1034CS
Tergooi Medisch Centrum
Blaricum, North Holland, 1261AN
Amphia Ziekenhuis
Breda, North Brabant, 4818CK
Medisch Spectrum Twente
Enschede, Overijssel, 7512KZ
Franciscus Gasthuis & Vlietland
Rotterdam, South Holland, 3045PM
Juliana Kinderziekenhuis
The Hague, South Holland, 2545AA
Zaans Medisch Centrum
Zaandam, North Holland, 1502DV
About this study
Official title: Collaborating to Improve Neonatal Care: ParentAl paRticipation on The NEonatal waRd - the neoPARTNER Study
Objective: To investigate the effect of FCR as part of the FICare principles during hospital stay, on parental stress at discharge in parents of preterm or ill infants admitted to the neonatal ward for >7 days as compared to standard medical rounds (SMR) without parents as part of standard neonatal care (SNC).
Read the detailed description
Parents are often appointed a passive role during the admission of their preterm (born before 37 weeks of gestational age) or illinfant. Multiple studies have demonstrated that information and communication are crucial for families of intensive care patients.However, common practice in neonatal wards regarding daily rounds is that the medical rounds are only attended by the physicianand nurse without presence and participation of the parents. Parents are usually updated by the nurse afterwards. Family CentredRounds (FCR) include parents on daily rounds (digital or physical presence), involving them in the process of patient management,allowing them to hear their infants' conditions first-hand, to provide information on their child's general wellbeing themselves and toask questions and participate in shared decision making. Family Integrated Care (FICare) comprises a framework to implement FCRby bringing parents, medical and nursing staff together and involving parents as equal partners, minimizing separation, andsupporting parent-infant closeness. FICare consists of a collaborative program of psychological, educational, communication, andenvironmental strategies to support parents to cope with neonatatal environment and to prepare them to be able to emotionally,cognitively, and physically care for their infant.
Objective of the study: To investigate the effect of FCR during hospital stay, accompanied by FICare, on parental stress at discharge in parents of preterm(born before 37 weeks of gestational age) or ill (for instance with sepsis or small for gestational age) infants admitted to the neonatalward for >7 days as compared to standard daily rounds (SDR) without parents with SNC. We primarily hypothesize that FCR andFICare are superior to SNC with regard to parental stress at discharge. Secondary outcomes in parents include participation inneonatal care, experience in shared decision making, parent-infant bonding, biomarkers of stress (in hair and saliva), breastmilkcomposition and the longitudinal course of parent mental health after infant discharge. Infant outcomes include breastfeeding atdischarge, growth, biomarkers of stress in saliva and length of hospital stay. For healthcare professionals outcomes such as workengagement and autonomy will be analysed at the cluster level. Cost-effectiveness analysis will be done as well at the level ofparents and healthcare professionals.
Study design: A multicentre stepped wedge cluster randomised trial will be conducted. A total of 10 hospitals with a level 2 neonatal ward in theNetherlands will participate. Timing of start of intervention will be randomised between sites.
Study population: All (parents of) infants admitted to the neonatal ward directly after birth, or transferred to a participating centre after birth in aneonatal intensive care unit (NICU) are eligible for participation in the study.
Intervention (if applicable): The intervention will consist of parental participation in medical rounds (FCR). Parents and healthcare professionals will besupported by the four pillars of FICare: parent education, education of healthcare professionals, psychosocial support andenvironment of the neonatal ward.
Primary study parameters/outcome of the study: The main outcome is parental stress at discharge, as defined by the total score on the Parental Stress Scale (PSS:NICU). ThePSS:NICU is a three-dimensional tool, in which parents express the amount of stress they experienced by rating 26 items on a 5-point Likert scale ("not stressful at all" to "extremely stressful").
Secundary study parameters/outcome of the study (if applicable): Secondary outcome measures on the individual level will be parent participation in neonatal care, parent-infant bonding andexperiences in shared decision making. The longitudinal course of parental mental health (anxiety, depression, posttraumatic stress)will be analyzed, as well as biomarkers of stress (in saliva, hair and breastmilk) and breastmilk composition. Also, neonatalsecondary outcome measures will be taken into account, specifically length of stay, breastfeeding rates at discharge, biomarkers ofstress in saliva and growth. On the cluster level we will study professional secondary outcome measures such as work engagementand autonomy.
- Conditions
- Premature, Premature Birth, Prematurity, Perinatal Problems, Neonatal Sepsis, Neonatal Infection
- Being tested
- Family Integrated Care
- Keywords
- Family Centred Rounds, Family Integrated Care, Shared Decision Making, Parent participation
- Medical subject headings
- Premature Birth, Neonatal Sepsis, Hyperbilirubinemia, Neonatal, Disease, Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Integrated CareOther
The intervention will consist of FICare, including parental participation in medical rounds (FCR). Parents and healthcare professionals will be educated and supported by the four pillars of FICare: parent education, education of healthcare professionals, psychosocial support and a supportive environment of the neonatal ward.
| Study group | Role | What they receive |
|---|---|---|
| Family Integrated Care | During the intervention period, Family Integrated Care (FICare) will be implemented on the neonatal wards of the participating hospitals. Families that are included during this intervention period will participate in Family Centred Rounds (FCR), while being supported by the principles of FICare. FICare incorporates psychological, educational, communication, and environmental strategies to support parents and to prepare them emotionally, cognitively, and physically to care autonomously for their infant at the time of discharge. In FCR, parents actively participate in the medical rounds and decisions are made based on shared-decision making. Not only are parents informed about the clinical condition of their child, they can ask questions and share their own valuable information on their child. Such information can include the overall wellbeing but also specific medical information. Receives: Other: Family Integrated Care | |
| Standard Neonatal Care | In the control period, standard neonatal care (SNC) will be provided. Medical rounds will be held between healthcare professionals, and parents are not (structurally) participating during these rounds. Parents are updated daily by the nurses, and (usually) weekly by their attending physician. Care for the infants is provided mostly by the nurses. Parents usually have (unlimited) access to the ward, but are not supported by the concept of FICare. As such, they do not receive education and are not structurally supported by veteran parents. Healthcare professionals stimulate parents to participate in daily care (such as feedings or skin-to-skin care), but do not receive structural education on how to incorporate parents as equal partners into the care team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of parental stress
Patient Reported Outcome: Parental Stress Scale: Neonatal Intensive Care Unit (Miles, 1993). Range: 0-135 points, higher score indicating higher levels of parental stress.
Measured: Immediately after intervention (at discharge of the infant)
Secondary outcomes (16)
Experiences of Shared Decision Making
Patient Reported Outcome: Shared Decision Making Questionnaire (SDM-Q-9, Kriston et al. 2010). Range: original score of 0-45 points calculated into score with range of 0-100 points, higher score indicating higher levels of shared decision making.
Measured: Immediately after intervention (at discharge of the infant)
Parent-infant attachment
Maternal (or Paternal) Postnatal Attachment Scale (Condon et al., 1998). Range: 19-95 points, lower score indicating problematic mother-to-infant bonding or father-to-infant bonding, respectively.
Measured: Immediately after intervention (at discharge of the infant)
Level of parental participation in neonatal care
Patient Reported Outcome: CO-PARTNER tool (van Veenendaal et al, 2021). Range: 0-62, higher score indicating higher level of participation.
Measured: Immediately after intervention (at discharge of the infant)
Symptoms of parental depression
Patient Reported Outcome: PROMIS Depression, Shortform (PROMIS Health Organisation). Range: 8-40 points (calculated into a T-score with a mean of 50 and a standard deviation of 10), higher score indicating more symptoms of depression.
Measured: Pre- and post-intervention, measured at discharge of the infant through study completion at the (corrected) age of 12 months
Symptoms of parental anxiety
Patient Reported Outcome: PROMIS Anxiety, Shortform (PROMIS Health Organisation). Range: 8-40 points (calculated into a T-score with a mean of 50 and a standard deviation of 10), higher score indicating more symptoms of anxiety.
Measured: Pre- and post-intervention, measured at discharge of the infant through study completion at the (corrected) age of 12 months, 3, 6 and 12 months corrected age
Symptoms of parental posttraumatic stress
Patient Reported Outcome: Post-traumatic Stress Disorder Checklist for DSM-5 (Weathers et al., 2013). Range: 0-80, higher score indicating more symptoms of posttraumatic stress.
Measured: Pre- and post-intervention, measured at discharge of the infant through study completion at the (corrected) age of 12 months
Cost-effectiveness on parent and infant level
Patient Reported Outcome: Productivity Cost Questionnaire \& Medical Consumption Questionnaire (Bouwmans et al, 2015 \& 2013, respectively). No scale applicable.
Measured: At the corrected age of 12 months.
Infant development
Patient Reported Outcome: Ages and Stages Questionnaire, edition 3 (Flamant et al, 2011). Range: 0-300 points, higher score indicating better infant development.
Measured: At the corrected age of 12 months.
Length of hospital stay (infant)
Duration of the hospital admission of the infant, expressed in days.
Measured: During intervention (estimated average of 21 days).
Amount of breastfeeding
Amount of breastfeeding defined as percentage of total (enteral) intake
Measured: Immediately after intervention (at discharge of the infant).
Infant growth
Rate of weight gain during hospital stay and during first year of life.
Measured: Pre- and post-intervention, measured at discharge of the infant through study completion at the (corrected) age of 12 months
Change in experience of Shared decision making (healthcare professionals)
Self-reported outcome: Shared Decision Making Questionnaire-Physician Version. (Rodenburg-Vandenbussche et al., 2015). Range: original score of 0-45 points calculated into score with range of 0-100 points, higher score indicating higher levels of shared decision making.
Measured: Through study completion, an average of 21 months.
Change in experienced work engagement (healthcare professionals)
Self-reported outcome: Utrechtse Work Engagement Scale (Schaufeli et al., 2003). Range: 0-6 points, higher score indicating higher levels of work engagement.
Measured: Through study completion, an average of 21 months.
Change in experienced work autonomy (healthcare professionals)
Self-reported outcome: Job Content Questionnaire, Decision Authority Subscale (Karasek et al., 1998). Range: 3-12 points, higher score indicating more feeling of autonomy.
Measured: Through study completion, an average of 21 months.
Cost-effectiveness (healthcare professionals)
Work absence as registered at the hospital administration, and self-reported outcome: Productivity Cost Questionnaire (Bouwmans et al., 2015). No range applicable.
Measured: Through study completion, an average of 21 months.
Family Centred Rounds
% of medical rounds with parental presence as reported by healthcare professionals
Measured: Through study completion, an average of 21 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start7 Mar 2022
- Primary completion2 Feb 2024
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PrematureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 613 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouwe Gasthuis
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Responsible party
- Principal investigator, Dr. Sophie van der Schoor, Onze Lieve Vrouwe Gasthuis
- Investigators
- Sophie van der Schoor, Dr., Principal investigator, OLVG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343403
- Sponsor's protocol ID
- NL78176.100.21
- Acronym
- neoPARTNER
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2022
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hoeben H, Alferink MT, van Kempen AAMW, van Goudoever JB, van Veenendaal NR, van der Schoor SRD, On Behalf Of The neoPARTNER Study Group. Collaborating to Improve Neonatal Care: ParentAl Participation on the NEonatal Ward-Study Protocol of the neoPARTNER Study. Children (Basel). 2023 Aug 30;10(9):1482. doi: 10.3390/children10091482.
PubMed 37761442Alferink MT, Hoeben H, Jonkman NH, van Goudoever JB, van Kempen AAMW, van Veenendaal NR, van der Schoor SRD; neoPARTNER studygroup. Family integrated care reduces stress in transferred parents of preterm infants, but not across all families: a stepped-wedge cluster-randomized trial. J Perinatol. 2025 Jun;45(6):797-805. doi: 10.1038/s41372-025-02318-w. Epub 2025 May 20.
PubMed 40394238
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborating to Improve Neonatal Care: ParentAl paRticipation on The NEonatal waRd - the neoPARTNER Study
- ClinicalTrials.gov ID
- NCT05343403
- Acronym / sponsor ID
- neoPARTNER / NL78176.100.21
- Conditions
- Premature, Premature Birth, Prematurity, Perinatal Problems, Neonatal Sepsis, Neonatal Infection
- Keywords
- Family Centred Rounds, Family Integrated Care, Shared Decision Making, Parent participation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 613 participants (actual)
- Lead sponsor
- Onze Lieve Vrouwe GasthuisUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 25 Apr 2022 (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.
Objective: To investigate the effect of FCR as part of the FICare principles during hospital stay, on parental stress at discharge in parents of preterm or ill infants admitted to the neonatal ward for >7 days as compared to standard medical rounds (SMR) without parents as part of standard neonatal care (SNC).
Detailed description
Parents are often appointed a passive role during the admission of their preterm (born before 37 weeks of gestational age) or illinfant. Multiple studies have demonstrated that information and communication are crucial for families of intensive care patients.However, common practice in neonatal wards regarding daily rounds is that the medical rounds are only attended by the physicianand nurse without presence and participation of the parents. Parents are usually updated by the nurse afterwards. Family CentredRounds (FCR) include parents on daily rounds (digital or physical presence), involving them in the process of patient management,allowing them to hear their infants' conditions first-hand, to provide information on their child's general wellbeing themselves and toask questions and participate in shared decision making. Family Integrated Care (FICare) comprises a framework to implement FCRby bringing parents, medical and nursing staff together and involving parents as equal partners, minimizing separation, andsupporting parent-infant closeness. FICare consists of a collaborative program of psychological, educational, communication, andenvironmental strategies to support parents to cope with neonatatal environment and to prepare them to be able to emotionally,cognitively, and physically care for their infant.
Objective of the study: To investigate the effect of FCR during hospital stay, accompanied by FICare, on parental stress at discharge in parents of preterm(born before 37 weeks of gestational age) or ill (for instance with sepsis or small for gestational age) infants admitted to the neonatalward for >7 days as compared to standard daily rounds (SDR) without parents with SNC. We primarily hypothesize that FCR andFICare are superior to SNC with regard to parental stress at discharge. Secondary outcomes in parents include participation inneonatal care, experience in shared decision making, parent-infant bonding, biomarkers of stress (in hair and saliva), breastmilkcomposition and the longitudinal course of parent mental health after infant discharge. Infant outcomes include breastfeeding atdischarge, growth, biomarkers of stress in saliva and length of hospital stay. For healthcare professionals outcomes such as workengagement and autonomy will be analysed at the cluster level. Cost-effectiveness analysis will be done as well at the level ofparents and healthcare professionals.
Study design: A multicentre stepped wedge cluster randomised trial will be conducted. A total of 10 hospitals with a level 2 neonatal ward in theNetherlands will participate. Timing of start of intervention will be randomised between sites.
Study population: All (parents of) infants admitted to the neonatal ward directly after birth, or transferred to a participating centre after birth in aneonatal intensive care unit (NICU) are eligible for participation in the study.
Intervention (if applicable): The intervention will consist of parental participation in medical rounds (FCR). Parents and healthcare professionals will besupported by the four pillars of FICare: parent education, education of healthcare professionals, psychosocial support andenvironment of the neonatal ward.
Primary study parameters/outcome of the study: The main outcome is parental stress at discharge, as defined by the total score on the Parental Stress Scale (PSS:NICU). ThePSS:NICU is a three-dimensional tool, in which parents express the amount of stress they experienced by rating 26 items on a 5-point Likert scale ("not stressful at all" to "extremely stressful").
Secundary study parameters/outcome of the study (if applicable): Secondary outcome measures on the individual level will be parent participation in neonatal care, parent-infant bonding andexperiences in shared decision making. The longitudinal course of parental mental health (anxiety, depression, posttraumatic stress)will be analyzed, as well as biomarkers of stress (in saliva, hair and breastmilk) and breastmilk composition. Also, neonatalsecondary outcome measures will be taken into account, specifically length of stay, breastfeeding rates at discharge, biomarkers ofstress in saliva and growth. On the cluster level we will study professional secondary outcome measures such as work engagementand autonomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Integrated Care | – | Other: Family Integrated CareDuring the intervention period, Family Integrated Care (FICare) will be implemented on the neonatal wards of the participating hospitals. Families that are included during this intervention period will participate in Family Centred Rounds (FCR), while being supported by the principles of FICare. FICare incorporates psychological, educational, communication, and environmental strategies to support parents and to prepare them emotionally, cognitively, and physically to care autonomously for their infant at the time of discharge. In FCR, parents actively participate in the medical rounds and decisions are made based on shared-decision making. Not only are parents informed about the clinical condition of their child, they can ask questions and share their own valuable information on their child. Such information can include the overall wellbeing but also specific medical information. |
| Standard Neonatal Care | – | –In the control period, standard neonatal care (SNC) will be provided. Medical rounds will be held between healthcare professionals, and parents are not (structurally) participating during these rounds. Parents are updated daily by the nurses, and (usually) weekly by their attending physician. Care for the infants is provided mostly by the nurses. Parents usually have (unlimited) access to the ward, but are not supported by the concept of FICare. As such, they do not receive education and are not structurally supported by veteran parents. Healthcare professionals stimulate parents to participate in daily care (such as feedings or skin-to-skin care), but do not receive structural education on how to incorporate parents as equal partners into the care team. |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 600 preterm or ill infants, admitted 37 days to a level 2 neonatal ward, with their parents (600 mothers and 600 fathers/partners) will be included in this study. Moreover, healthcare professionals working at the different hospitals will be included as well.
Key inclusion criteria (3 listed)
- Infant requiring hospital admission directly (within 24 hours) after birth;
- Parent of 18 years or older;
- Written informed consent of both parents.
Key exclusion criteria (6 listed)
- Infant's hospital stay shorter than 7 days;
- Infant with severe congenital or syndromal anomaly;
- Infant with critical illness who is unlikely to survive;
- Parent with current psychosocial problems (such as posttraumatic stress disorder, schizophrenia or psychotic disorders) with or without medication which have not been stable over the past year;
- Involvement of child protective services in the family;
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 |
|---|---|---|
| Family Integrated CareThe intervention will consist of FICare, including parental participation in medical rounds (FCR). Parents and healthcare professionals will be educated and supported by the four pillars of FICare: parent education, education of healthcare professionals, psychosocial support and a supportive environment of the neonatal ward. | Other | Family Integrated Care |
Primary outcome
Level of parental stress
Time frame: Immediately after intervention (at discharge of the infant)
Patient Reported Outcome: Parental Stress Scale: Neonatal Intensive Care Unit (Miles, 1993). Range: 0-135 points, higher score indicating higher levels of parental stress.
16 secondary outcomes
Experiences of Shared Decision Making
Time frame: Immediately after intervention (at discharge of the infant)
Parent-infant attachment
Time frame: Immediately after intervention (at discharge of the infant)
Level of parental participation in neonatal care
Time frame: Immediately after intervention (at discharge of the infant)
Symptoms of parental depression
Time frame: Pre- and post-intervention, measured at discharge of the infant through study completion at the (corrected) age of 12 months
Symptoms of parental anxiety
Time frame: Pre- and post-intervention, measured at discharge of the infant through study completion at the (corrected) age of 12 months, 3, 6 and 12 months corrected age
Symptoms of parental posttraumatic stress
Time frame: Pre- and post-intervention, measured at discharge of the infant through study completion at the (corrected) age of 12 months
Cost-effectiveness on parent and infant level
Time frame: At the corrected age of 12 months.
Infant development
Time frame: At the corrected age of 12 months.
Length of hospital stay (infant)
Time frame: During intervention (estimated average of 21 days).
Amount of breastfeeding
Time frame: Immediately after intervention (at discharge of the infant).
Infant growth
Time frame: Pre- and post-intervention, measured at discharge of the infant through study completion at the (corrected) age of 12 months
Change in experience of Shared decision making (healthcare professionals)
Time frame: Through study completion, an average of 21 months.
Change in experienced work engagement (healthcare professionals)
Time frame: Through study completion, an average of 21 months.
Change in experienced work autonomy (healthcare professionals)
Time frame: Through study completion, an average of 21 months.
Cost-effectiveness (healthcare professionals)
Time frame: Through study completion, an average of 21 months.
Family Centred Rounds
Time frame: Through study completion, an average of 21 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 37761442Hoeben H, Alferink MT, van Kempen AAMW, van Goudoever JB, van Veenendaal NR, van der Schoor SRD, On Behalf Of The neoPARTNER Study Group. Collaborating to Improve Neonatal Care: ParentAl Participation on the NEonatal Ward-Study Protocol of the neoPARTNER Study. Children (Basel). 2023 Aug 30;10(9):1482. doi: 10.3390/children10091482.
- Derived from this study: PubMed 40394238Alferink MT, Hoeben H, Jonkman NH, van Goudoever JB, van Kempen AAMW, van Veenendaal NR, van der Schoor SRD; neoPARTNER studygroup. Family integrated care reduces stress in transferred parents of preterm infants, but not across all families: a stepped-wedge cluster-randomized trial. J Perinatol. 2025 Jun;45(6):797-805. doi: 10.1038/s41372-025-02318-w. Epub 2025 May 20.
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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.
Sophie van der Schoor, Dr. principal investigator
OLVG
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature and Premature Birth, run by Onze Lieve Vrouwe Gasthuis at 10 sites in Netherlands.
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 3 inclusion and 6 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 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands. 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?
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?
Level of parental stress (time frame: Immediately after intervention (at discharge of the infant)). 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 NCT05343403, which also lists 2 linked publications.
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 6 Feb 2024.