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Family Integrated Care in the Neonatal Ward


- candidate number25466
- NTR NumberNTR6192
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-okt-2016
- Secondary IDsNL/ABR 056691 
- Public TitleFamily Integrated Care in the Neonatal Ward
- Scientific TitlefAMily Integrated CAre in the neonatal ward
- ACRONYMthe AMICA-study
- hypothesis In this study we want to explore the effect of Family Integrated Care in Single Family Rooms in a level 2 Neonatal Ward in preterm infants with a postconceptional age 30 weeks until discharge. In line of studies done in the NICU setting with FIC our hypothesis is that implementation of Family Integrated Care in single family rooms in a level 2 Neonatal Ward is superior to standard neonatal care in open bay units concerning psychomotor development at 2 years (corrected) aged and parental stress.
- Healt Condition(s) or Problem(s) studiedPremature infants, Neonates, Nurse practitioner
- Inclusion criteria Hospitalised children:
- Born between 24 and 36 6/7 weeks gestational age, with a postconceptional age 44 weeks on admission
- At least 1 week of hospital stay on the Neonatal Ward
- Will visit the Outpatient Clinic of the OLVG East, OLVG West or NWZA after discharge or consents to gather required information through infant health centers
- Written informed consent from the parents
- Exclusion criteria- Metabolic or chromosomal/syndromal diseases
- Therapeutic hypothermia for perinatal asphyxia
- Severe psychiatric or psychosocial problems i.e. parents under supervision of youth care
- Transfer to another hospital before discharge
- Parents are unable to answer the questionnaires in Dutch/English
- Death of an infant
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jan-2017
- planned closingdate1-jan-2021
- Target number of participants600
- InterventionsSingle Family Rooms and Family Integrated Care.
- Primary outcome1. To evaluate the effect of Family Integrated Care in SFR on neurodevelopmental outcome at 2 years of (corrected) age in newborns hospitalized in a level-2 Neonatal Ward for at least 1 week as compared to standard neonatal care in open bay units as measured by the Ages and Stages Questionnaire 3rd edition and the Bayleys Scale of Infant Development 3rd edition.
- Secondary outcomeNeonatal: growth, breastfeeding rates, days to enteral and/or oral feed (with and without tube-feeding), days of respiratory support (including days on extra oxygen), temperature stability, critical incidents, days, length of hospital stay, hospital readmission rates, iron status, and sepsis rates Parental: satisfaction/empowerment, parent-infant bonding, satisfaction/empowerment, parental self-efficacy, and degree of family centred care.
- Timepoints
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES AMICA studie groep
- CONTACT for SCIENTIFIC QUERIESMD/PhD N.R. van Veenendaal
- Sponsor/Initiator Onze Lieve Vrouwe Gasthuis (OLVG)
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Nederland B.V.
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD28-okt-2016 - 5-mrt-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl