Parental Participation on the Neonatal Ward - the neoPARTNER Study

Premature Birth Clinical Trial

— neoPARTNER  

Official title:

Collaborating to Improve Neonatal Care: ParentAl paRticipation on The NEonatal waRd - the neoPARTNER Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05343403
• Other study ID #: NL78176.100.21
• Status: Active, not recruiting
• Start date: March 7, 2022
• Est. completion date: March 1, 2025

Study information

• Verified date: February 2024
• Source: Onze Lieve Vrouwe Gasthuis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 613
• Est. completion date: March 1, 2025
• Est. primary completion date: February 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day and older

Eligibility

Inclusion Criteria:

• Infant requiring hospital admission directly (within 24 hours) after birth;

• Parent of 18 years or older;

• Written informed consent of both parents.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Infant Development
• Infant, Newborn, Disease
• Infant, Newborn, Diseases
• Infant, Premature, Diseases
• Infant, Small for Gestational Age
• Maternal Distress
• Neonatal Hyperbilirubinemia
• Neonatal Infection
• Neonatal Sepsis
• Parent-Child Relations
• Parents
• Perinatal Problems
• Premature
• Premature Birth
• Prematurity
• Small for Gestational Age Infant

Intervention

Other:
• Family Integrated Care
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.

Locations

Country	Name	City	State
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar	Noord Holland
Netherlands	Flevoziekenhuis	Almere	Flevoland
Netherlands	Ziekenhuis Amstelland	Amstelveen	Noord Holland
Netherlands	BovenIJ Ziekenhuis	Amsterdam	Noord Holland
Netherlands	Tergooi Medisch Centrum	Blaricum	Noord Holland
Netherlands	Amphia Ziekenhuis	Breda	Brabant
Netherlands	Juliana Kinderziekenhuis	Den Haag	Zuid Holland
Netherlands	Medisch Spectrum Twente	Enschede	Overijssel
Netherlands	Franciscus Gasthuis & Vlietland	Rotterdam	Zuid Holland
Netherlands	Zaans Medisch Centrum	Zaandam	Noord Holland

Sponsors (2)

Lead Sponsor	Collaborator
Onze Lieve Vrouwe Gasthuis	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediately after intervention (at discharge of the infant)
Secondary	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.	Immediately after intervention (at discharge of the infant)
Secondary	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.	Immediately after intervention (at discharge of the infant)
Secondary	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.	Immediately after intervention (at discharge of the infant)
Secondary	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.	Pre- and post-intervention, measured at discharge of the infant through study completion at the (corrected) age of 12 months
Secondary	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.	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
Secondary	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.	Pre- and post-intervention, measured at discharge of the infant through study completion at the (corrected) age of 12 months
Secondary	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.	At the corrected age of 12 months.
Secondary	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.	At the corrected age of 12 months.
Secondary	Length of hospital stay (infant)	Duration of the hospital admission of the infant, expressed in days.	During intervention (estimated average of 21 days).
Secondary	Amount of breastfeeding	Amount of breastfeeding defined as percentage of total (enteral) intake	Immediately after intervention (at discharge of the infant).
Secondary	Infant growth	Rate of weight gain during hospital stay and during first year of life.	Pre- and post-intervention, measured at discharge of the infant through study completion at the (corrected) age of 12 months
Secondary	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.	Through study completion, an average of 21 months.
Secondary	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.	Through study completion, an average of 21 months.
Secondary	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.	Through study completion, an average of 21 months.
Secondary	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.	Through study completion, an average of 21 months.
Secondary	Family Centred Rounds	% of medical rounds with parental presence as reported by healthcare professionals	Through study completion, an average of 21 months.