Parental Participation on the Neonatal Ward - the neoPARTNER Study

NCT05343403 | Active Not Recruiting DMC

• 1 other identifier: NL78176.100.21
• Study Type: observational
• Target: 613
• Locations: 1 country
• Sites: 10

Brief 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).

Conditions

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

Keywords

Family Centred Rounds; Family Integrated Care; Shared Decision Making; Parent participation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Experiences of Shared Decision Making

  Immediately after intervention (at discharge of the infant)

• Parent-infant attachment

  Immediately after intervention (at discharge of the infant)

• Level of parental participation in neonatal care

  Immediately after intervention (at discharge of the infant)

• Symptoms of parental depression

  Pre- and post-intervention, measured at discharge of the infant through study completion at the (corrected) age of 12 months

• Symptoms of parental 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

Study Arms (2)

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.

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.

Interventions

Family Integrated Care OTHER

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.

Family Integrated Care

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Infant requiring hospital admission directly (within 24 hours) after birth;
• Parent of 18 years or older;
• Written informed consent of both parents.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Onze Lieve Vrouwe Gasthuis: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (10)

Flevoziekenhuis

Almere Stad, Flevoland, 1315RA, Netherlands

Location

Amphia Ziekenhuis

Breda, North Brabant, 4818CK, Netherlands

Location

Noordwest Ziekenhuisgroep

Alkmaar, North Holland, 1815JD, Netherlands

Location

Ziekenhuis Amstelland

Amstelveen, North Holland, 1186AM, Netherlands

Location

BovenIJ Ziekenhuis

Amsterdam, North Holland, 1034CS, Netherlands

Location

Tergooi Medisch Centrum

Blaricum, North Holland, 1261AN, Netherlands

Location

Zaans Medisch Centrum

Zaandam, North Holland, 1502DV, Netherlands

Location

Medisch Spectrum Twente

Enschede, Overijssel, 7512KZ, Netherlands

Location

Franciscus Gasthuis & Vlietland

Rotterdam, South Holland, 3045PM, Netherlands

Location

Juliana Kinderziekenhuis

The Hague, South Holland, 2545AA, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 37761442 BACKGROUND

• Alferink 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.

  PMID: 40394238 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva, buccal mucosa, hair, human's milk

MeSH Terms

Conditions

Premature Birth; Neonatal Sepsis; Hyperbilirubinemia, Neonatal; Disease; Infant, Premature, Diseases

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperbilirubinemia

Study Officials

• Sophie van der Schoor, Dr.

  OLVG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: April 25, 2022
• Study Start: March 7, 2022
• Primary Completion: February 2, 2024
• Study Completion: March 1, 2025
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

NL (10)