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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list