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Family Integrated Care in the Neonatal Ward - the AMICA study


- candidate number25688
- NTR NumberNTR6322
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-dec-2016
- Secondary IDs56691 NLABR
- Public TitleFamily Integrated Care in the Neonatal Ward - the AMICA study
- Scientific TitleFamily Integrated Care in the Neonatal Ward - the AMICA study
- ACRONYMAMICA
- hypothesisFamily Integrated Care in Single Family Rooms improves neurodevelopmental outcome in preterm infants
- Healt Condition(s) or Problem(s) studiedPrematurity
- Inclusion criteriaHospitalised 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

Healthy controls:
Born at term (37 C 41 weeks of gestational age)
- Spontaneous vaginal birth without hospitalisation post-partum
- Written informed consent from the parents
- Exclusion criteriaMetabolic 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-feb-2017
- planned closingdate1-feb-2021
- Target number of participants600
- InterventionsSingle Family Rooms with Family Integrated Care
- Primary outcomeNeurodevelopment
- Secondary outcomeBreastfeeding, length of stay,
- Timepointsduring hospital stay, discharge, and 1,3,6,12,18 and 24 months of corrected age.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Nicole Van Veenendaal
- CONTACT for SCIENTIFIC QUERIES Nicole Van Veenendaal
- Sponsor/Initiator Onze Lieve Vrouwe Gasthuis (OLVG), Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Onze Lieve Vrouwe Gasthuis (OLVG)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD23-dec-2016 - 27-mei-2017


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