No registrations found.
ID
Source
Brief title
Intervention
Outcome measures
Primary outcome
Growth and body composition (bone density, fat percentage).
Secondary outcome
1. Anemia;
2. bone markers;
3. protein status;
4. metabolism (o.a. glucose, cholesterol, IGF-I);
5. free fatty acids in red blood cells;
6. neurodevelopment.
Background summary
N/A
Study objective
To study the effects of post dicharge nutrition on the growth, body composition, metabolism and neurodevelopment of premature infants .
To study the effects of catch-up growth on the body composition, metabolism and neurodevelopment of premature infants.
Intervention
Randomization to post discharge or term formula between 0 and 6 months corrected age. Breast milk group as a control group.
All the formula and the breast milk with fortifier are prescribed in a volume of ± 175 ml/kg/day (160-190ml/kg/day).
The infants are seen at the outpatient clinic at 0, 3, 6, 12 and 24 months corrected age. Anthropometry is performed and motorneurodevelopment is tested by a physiotherapist. At 0, 3 and 6 months corrected age a fasting venous blood sample is taken and urine is collected. At 0 and 6 months corrected age the body composition is established with a DEXA scan. Parents keep weekly dairies and telephonic support is offered on a regular bases.
Department of Paediatrics/Neonatology,
P.O. Box 7057, dep 9D11
E.M. Amesz
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4442480
eline.amesz@vumc.nl
Department of Paediatrics/Neonatology,
P.O. Box 7057, dep 9D11
E.M. Amesz
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4442480
eline.amesz@vumc.nl
Inclusion criteria
Gestational age <= 32 weeks with a birth weight <= 2000 grams or a birth weight <= 1500 grams and a gestational age <= 34 weeks.
At least one parent or caretaker who speaks Dutch or English.
Exclusion criteria
Conditions that influence the growth like:
1. Severe congenital anomalies;
2. Bronchopulmonary dysplasia defined as an O2 requirement above 25% at 36 weeks gestation, any O2 requirement at 38 weeks gestation or any respiratory support at 40 weeks gestatio';
3. Severe intracerebral haemorrhage or ischaemia diagnosed before inclusion;
4. Gastrointestinal surgery and gastro-intestinal diseases known to influence growth.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL32 |
| NTR-old | NTR55 |
| Other | : N/A |
| ISRCTN | ISRCTN53695702 |
Summary results
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Brief summary: Feeding nutrient-enriched formula without extra energy after term does not change quantity of growth, but does influence type of weight gain and body composition of preterm infants. Infants fed the nutrient-enriched formula had lower fat mass corrected for body size at six months corrected age than infants fed standard formula or human milk. There were no differences in growth or body size between infants fed postdischarge formula, standard formula, and human milk.