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
Protocol serial number	N/A
Sponsor	Erasmus Medical Centre (The Netherlands)
Funder	Erasmus Medical Centre (The Netherlands)

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

Prof 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

Primary study design	Interventional
Study design	Randomised placebo-controlled parallel-group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	TOL
Study objectives	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(s)	Approval received from the local ethics committee (Medical Ethical Committee), 13/11/2006, ref: METC-2006-268
Health condition(s) or problem(s) studied	Premature infants
Intervention	Bolus intermittent nasogastric feeding versus semi-continuous milk feeding.
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	05/02/2008

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	250
Key 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
Key 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
Date of first enrolment	05/02/2006
Date of final enrolment	05/02/2008

Erasmus Medical Centre

Rotterdam
3000 CB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan