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 |
| Protocol serial number | N/A |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Funder | Academic Medical Centre (AMC) (The Netherlands) - Emma Children's Hospital |
- 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
Scientific
VU Medical Centre
De Boelelaan 1117
P.O. Box 7075
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 444 2424 |
|---|---|
| r.vanbaren@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised placebo-controlled factorial trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | MEF protocol |
| Study objectives | With 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) studied | 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 |
| Primary outcome measure(s) |
Number of days from the operation to enteral feeding of 120 ml/kg/day. |
| Key secondary outcome measure(s) |
1. Weight gain on day 20 postoperative compared to birth weight |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. All neonates with gastroschisis, omphalocele, duodenal and small bowel atresia who underwent surgical correction 2. Informed consent of the parents |
| Key exclusion criteria | 1. No informed consent of the parents 2. Pre-operative bowel perforation 3. Per-operative need for a stoma |
| Date of first enrolment | 13/06/2002 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU Medical Centre
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
