The effect of intermittent bolus nasogastric milk feeding versus semi-continuous milk feeding in preterm infants on TOLerance

ISRCTN ISRCTN42413683
DOI https://doi.org/10.1186/ISRCTN42413683
Secondary identifying numbers N/A
Submission date
08/02/2007
Registration date
08/02/2007
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

Professor J B van Goudoever
Scientific

Erasmus Medical Centre
Sophia Children's Hospital
P.O. Box 2060
Rotterdam
3000 CB
Netherlands

Phone +31 (0)10 463 6363
Email j.vangoudoever@erasmusmc.nl

Study information

Study designRandomised placebo-controlled parallel-group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymTOL
Study objectivesPremature 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(s)Approval received from the local ethics committee (Medical Ethical Committee), 13/11/2006, ref: METC-2006-268
Health condition(s) or problem(s) studiedPremature infants
InterventionBolus intermittent nasogastric feeding versus semi-continuous milk feeding.
Intervention typeOther
Primary outcome measureTo 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 measures1. 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 study start date05/02/2006
Completion date05/02/2008

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants250
Key inclusion criteria1. Admission to neonatal intensive care unit within 24 hours after birth
2. Gestational age under 32 weeks
3. Birth weight less than 1750 g
Key exclusion criteria1. 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
Date of first enrolment05/02/2006
Date of final enrolment05/02/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus Medical Centre
Rotterdam
3000 CB
Netherlands

Sponsor information

Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre

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

Website http://www.erasmusmc.nl/#http://www.erasmusmc.nl/
ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Hospital/treatment centre

Erasmus Medical Centre (The Netherlands)

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