Condition category
Neonatal Diseases
Date applied
08/02/2007
Date assigned
08/02/2007
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

Professor J B van Goudoever

ORCID ID

Contact details

Erasmus Medical Centre
Sophia Children's Hospital
P.O. Box 2060
Rotterdam
3000 CB
Netherlands
+31 (0)10 463 6363
j.vangoudoever@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

TOL

Study hypothesis

Premature infants born under 32 weeks tolerate bolus feeding better than semi-continuous nasogastric milk feeding, so that the number of days to reach full enteral feeding are less.

Ethics approval

Approval received from the local ethics committee (Medical Ethical Committee), 13/11/2006, ref: METC-2006-268

Study design

Randomised placebo-controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Premature infants

Intervention

Bolus intermittent nasogastric feeding versus semi-continuous milk feeding.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To assess the effect on both feeding regimes on feeding tolerance. Primary objective is days to reach full enteral feedings, defined as more than or equal to 120 mL/kg/d.

Secondary outcome measures

1. Secondary objective is number of feeding interruptions, days on total parenteral nutrition and number of apnea episodes per day
2. To assess somatic growth in both feeding regimes. To evaluate this variable, the following items will be used: days to regain birth weight, rates of weight gain, knemometry and head circumference
3. To assess complications in both groups measured as catheter related sepsis and necrotising enterocolitis

Overall trial start date

05/02/2006

Overall trial end date

05/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Admission to neonatal intensive care unit within 24 hours after birth
2. Gestational age under 32 weeks
3. Birth weight less than 1750 g

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

250

Participant exclusion criteria

1. Simultaneous participation in another trial of which the intervention may influence this trials endpoints
2. Congenital gastrointestinal obstructions like duodenal atresia, anal atresia, etc.
3. Any disease entity known to encompass impaired growth other than small gestational age
4. No informed consent

Recruitment start date

05/02/2006

Recruitment end date

05/02/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Centre
Rotterdam
3000 CB
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

Sophia Children's Hospital
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/#http://www.erasmusmc.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus Medical Centre (The Netherlands)

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