Condition category
Neonatal Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
09/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amc.uva.nl/

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

Publication citations

Additional files

Editorial Notes