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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NTR885 |
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Date of registration:
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02/02/2007 |
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Primary sponsor: |
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Public title:
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The effect of intermittent bolus nasogastric milk feeding versus semi-continuous milk feeding in preterm infants on TOLerance.
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Scientific title:
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The effect of intermittent bolus nasogastric milk feeding versus semi-continuous milk feeding in preterm infants on TOLerance. - The TOL-study |
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Date of first enrolment:
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5/2/2006 |
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Target sample size:
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250 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=885 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Placebo; Group: Parallel; Type: [default]
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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J.B.
Goudoever, van |
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Address:
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Erasmus Medical Center, Sophia Children's Hospital
P.O. Box 2060
3000 CB
Rotterdam
The Netherlands |
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Telephone:
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+31 (0)10 4636363 |
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Email:
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j.vangoudoever@erasmusmc.nl |
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Affiliation:
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Name:
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J.B.
Goudoever, van |
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Address:
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Erasmus Medical Center, Sophia Children's Hospital
P.O. Box 2060
3000 CB
Rotterdam
The Netherlands |
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Telephone:
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+31 (0)10 4636363 |
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Email:
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j.vangoudoever@erasmusmc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Admission to neonatal intensive care unit within 24 hrs after birth;
2. Gestational age under 32 weeks;
3. Birth weight less than 1750 grams.
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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Feeding tolerance, Premature infants, Intermittent feeding, Semi-continuous feeding
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Intervention(s)
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Bolus intermittent nasogastric feeding
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Primary Outcome(s)
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To assess the effect on both feeding regimes on feeding tolerance. Primary objective is days to reach full enteral feedings, defined as ¡Ý 120 mL/kg/d.
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Secondary Outcome(s)
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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 necrotizing enterocolitis.
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Secondary ID(s)
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ISRCTN42413683
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N/A
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Source(s) of Monetary Support
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Erasmus Medical Center, Sophia Children's Hospital
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