Clinical trial NCT05343403: Parental Participation on the Neonatal Ward - the neoPARTNER Study
Official title: Collaborating to Improve Neonatal Care: ParentAl paRticipation on The NEonatal waRd - the neoPARTNER Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Onze Lieve Vrouwe Gasthuis
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2022-04-25
Enrollment: 613
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Level of parental stress
timeFrame: Immediately after intervention (at discharge of the infant)
Secondary outcomes:
measure: Experiences of Shared Decision Making
timeFrame: Immediately after intervention (at discharge of the infant)
measure: Parent-infant attachment
timeFrame: Immediately after intervention (at discharge of the infant)
measure: Level of parental participation in neonatal care
timeFrame: Immediately after intervention (at discharge of the infant)
measure: Symptoms of parental depression
timeFrame: Pre- and post-intervention, measured at discharge of the infant through study completion at the (corrected) age of 12 months
measure: Symptoms of parental anxiety
timeFrame: 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
measure: Symptoms of parental posttraumatic stress
timeFrame: Pre- and post-intervention, measured at discharge of the infant through study completion at the (corrected) age of 12 months
measure: Cost-effectiveness on parent and infant level
timeFrame: At the corrected age of 12 months.
measure: Infant development
timeFrame: At the corrected age of 12 months.
measure: Length of hospital stay (infant)
timeFrame: During intervention (estimated average of 21 days).
measure: Amount of breastfeeding
timeFrame: Immediately after intervention (at discharge of the infant).
measure: Infant growth
timeFrame: Pre- and post-intervention, measured at discharge of the infant through study completion at the (corrected) age of 12 months
measure: Change in experience of Shared decision making (healthcare professionals)
timeFrame: Through study completion, an average of 21 months.
measure: Change in experienced work engagement (healthcare professionals)
timeFrame: Through study completion, an average of 21 months.
measure: Change in experienced work autonomy (healthcare professionals)
timeFrame: Through study completion, an average of 21 months.
measure: Cost-effectiveness (healthcare professionals)
timeFrame: Through study completion, an average of 21 months.
measure: Family Centred Rounds
timeFrame: Through study completion, an average of 21 months.
Other outcomes:
Locations:
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
state: Brabant
city: Almere
country: Netherlands
facility: Flevoziekenhuis
state: Flevoland
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
state: Noord Holland
city: Amstelveen
country: Netherlands
facility: Ziekenhuis Amstelland
state: Noord Holland
city: Amsterdam
country: Netherlands
facility: BovenIJ Ziekenhuis
state: Noord Holland
city: Blaricum
country: Netherlands
facility: Tergooi Medisch Centrum
state: Noord Holland
city: Zaandam
country: Netherlands
facility: Zaans Medisch Centrum
state: Noord Holland
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: Overijssel
city: Den Haag
country: Netherlands
facility: Juliana Kinderziekenhuis
state: Zuid Holland
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland
state: Zuid Holland
Study officials:
affiliation: OLVG
name: Sophie van der Schoor, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.