Contact information
Type
Scientific
Primary contact
Dr R. van Baren
ORCID ID
Contact details
VU Medical Centre
De Boelelaan 1117
P.O. Box 7075
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 2424
r.vanbaren@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
MEF protocol
Study hypothesis
With postoperative Minimal Enteral Feeding (MEF) the neonates can be fed completely enteral earlier than without MEF.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Multicentre randomised placebo-controlled factorial trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Duodenal and small bowel atresia, gastroschisis, omphalocele
Intervention
1. 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 type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Number of days from the operation to enteral feeding of 120 ml/kg/day.
Secondary outcome measures
1. Weight gain on day 20 postoperative compared to birth weight
2. Number of coag. neg. staph. (CNS) sepsis episodes
Overall trial start date
13/06/2002
Overall trial end date
01/01/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. All neonates with gastroschisis, omphalocele, duodenal and small bowel atresia who underwent surgical correction
2. Informed consent of the parents
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. No informed consent of the parents
2. Pre-operative bowel perforation
3. Per-operative need for a stoma
Recruitment start date
13/06/2002
Recruitment end date
01/01/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU Medical Centre
Amsterdam
1007 MB
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (Netherlands)
Sponsor details
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Centre (AMC) (The Netherlands) - Emma Children's Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary