The effect of intermittent bolus nasogastric milk feeding versus semi-continuous milk feeding in preterm infants on TOLerance
ISRCTN | ISRCTN42413683 |
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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
Scientific
Erasmus Medical Centre
Sophia Children's Hospital
P.O. Box 2060
Rotterdam
3000 CB
Netherlands
Phone | +31 (0)10 463 6363 |
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j.vangoudoever@erasmusmc.nl |
Study information
Study design | Randomised placebo-controlled parallel-group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | 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 study start date | 05/02/2006 |
Completion date | 05/02/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Neonate |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Centre
Rotterdam
3000 CB
Netherlands
3000 CB
Netherlands
Sponsor information
Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Sophia Children's Hospital
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
Website | http://www.erasmusmc.nl/#http://www.erasmusmc.nl/ |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |