Efficacy of Minimal Enteral Feeding in neonates after surgical correction of gastroschisis, omphalocele or intestinal atresias

ISRCTN ISRCTN96703143
DOI https://doi.org/10.1186/ISRCTN96703143
Secondary identifying numbers N/A
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
09/10/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr R. van Baren
Scientific

VU Medical Centre
De Boelelaan 1117
P.O. Box 7075
Amsterdam
1007 MB
Netherlands

Phone +31 (0)20 444 2424
Email r.vanbaren@amc.uva.nl

Study information

Study designMulticentre randomised placebo-controlled factorial trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymMEF protocol
Study objectivesWith postoperative Minimal Enteral Feeding (MEF) the neonates can be fed completely enteral earlier than without MEF.
Ethics approval(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedDuodenal and small bowel atresia, gastroschisis, omphalocele
Intervention1. 6 x 2 ml feeding (formula or breast) through the nasogastric tube, followed by 30 minute tube closure
2. 6 x 30 minute tube closure without feeding
3. Start enteral feeding if daily gastric retention is less than 25 ml/day
Intervention typeOther
Primary outcome measureNumber of days from the operation to enteral feeding of 120 ml/kg/day.
Secondary outcome measures1. Weight gain on day 20 postoperative compared to birth weight
2. Number of coag. neg. staph. (CNS) sepsis episodes
Overall study start date13/06/2002
Completion date01/01/2006

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants40
Key inclusion criteria1. All neonates with gastroschisis, omphalocele, duodenal and small bowel atresia who underwent surgical correction
2. Informed consent of the parents
Key exclusion criteria1. No informed consent of the parents
2. Pre-operative bowel perforation
3. Per-operative need for a stoma
Date of first enrolment13/06/2002
Date of final enrolment01/01/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

VU Medical Centre
Amsterdam
1007 MB
Netherlands

Sponsor information

Academic Medical Centre (AMC) (Netherlands)
University/education

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Website http://www.amc.uva.nl/
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Hospital/treatment centre

Academic Medical Centre (AMC) (The Netherlands) - Emma Children's Hospital

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan