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Brain Injury in Preterm infants: 'The BIMP study'


- candidate number27357
- NTR NumberNTR6485
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-jun-2017
- Secondary IDsNl52323.075.15 CCMO
- Public TitleBrain Injury in Preterm infants: 'The BIMP study'
- Scientific TitleBrain Injury in Moderate Preterm infants
- ACRONYMBIMP
- hypothesis
- Healt Condition(s) or Problem(s) studiedBrain damage, Preterm birth
- Inclusion criteria- GA 32-36 weeks;
- Admission to one of the neonatal wards of Isala Women-Children’s Hospital
- Exclusion criteria1) Congenital malformations of the central nervous system;
2) Chromosomal disorders;
3) Inborn errors of metabolism;
4) Congenital infections;
5) Central nervous system infections;
6) Parents do not speak Dutch or English
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-sep-2017
- planned closingdate
- Target number of participants254
- InterventionsCranial ultrasound and MRI
- Primary outcomePrevalence and characteristics of brain injury
- Secondary outcome- Relation between perinatal factors and brain injury
- Validity of cranial ultrasound for detection of brain injury as compared to MRI (considered the golden standard);
- Timepoints- day 3
- before discharge
- term equivalent age (TEA)
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc V. Boswinkel
- CONTACT for SCIENTIFIC QUERIESDr. G. Meijler
- Sponsor/Initiator Isala Women-Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Innovatie en Wetenschapsfonds Isala
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD7-jun-2017 - 10-jul-2017


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