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Efficacy of minimal enteral feeding in neonates after surgical correction of gastroschizis, omphalocele or intestinal atresias.


- candidate number1459
- NTR NumberNTR266
- ISRCTNISRCTN96703143
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR8-sep-2005
- Secondary IDsN/A 
- Public TitleEfficacy of minimal enteral feeding in neonates after surgical correction of gastroschizis, omphalocele or intestinal atresias.
- Scientific TitleEfficacy of minimal enteral feeding in neonates after surgical correction of gastroschizis, omphalocele or intestinal atresias.
- ACRONYMMEF protocol
- hypothesisWith postoperative minimal enteral feeding (MEF) the neonates can be fed completely enteral earlier than without MEF.
- Healt Condition(s) or Problem(s) studiedGastroschisis, Omphalocele, Duodenal- and Small bowel atresia
- Inclusion criteriaAll neonates with gastroschsis, omphalocele, duodenal- and small bowel atresia who underwent surgical correction. Informed consent of the parents.
- Exclusion criteria1. No informed consent of the parents;
2. Pre-operative bowel perforation;
3. Per-operative need for a stoma.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupFactorial
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 13-jun-2002
- planned closingdate1-jan-2006
- Target number of participants40
- Interventions1. 6 x 2 ml feeding (formula or breast) through the nasogastric tube, followed by 30 min. tube closure;
2. Compared to 6 x 30 min. tube closure without feeding;
3. Start enteral feeding if daily gastric retention is less than 25 ml/day.
- Primary outcomeNumber of days from the operation to enteral feeding of 120 ml/kg/day.
- Secondary outcome1. Weight gain on day 20 postoperative compared to birthweight;
2. Number of coag. neg. staph. (CNS) sepsis episodes.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. R. Baren, van
- CONTACT for SCIENTIFIC QUERIESDr. D.C. Aronson
- Sponsor/Initiator Academic Medical Center (AMC), Emma Children's Hospital, VU University Medical Center, Department of Pediatrics
- Funding
(Source(s) of Monetary or Material Support)
[default], Academic Medical Center (AMC), Emma Children's Hospital
- PublicationsThere are no publications on the efficacy of MEF after surgical corrections of congenital malformations. There are publications on MEF in prematures and term neonates on ventilation.
- Brief summaryIn neonates born with gastroschisis, omphalocele or intestinal atresias who underwent surgical correction, postoperative MEF is compared to no MEF: number of postoperative days to complete enteral feeding and CNS sepsis episodes are probably less and the weightgain more in the group receiving MEF.
- Main changes (audit trail)
- RECORD8-sep-2005 - 16-okt-2008


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