|- candidate number||0|
|- NTR Number||NTR55|
|- Date ISRCTN created||5-aug-2005|
|- date ISRCTN requested||28-jul-2005|
|- Date Registered NTR||21-jul-2005|
|- Secondary IDs||N/A |
|- Public Title||Study Towards the Effects of Post discharge nutrition on growth and body composition of infants born <= 32 weeks gestation and/or <= 1500 grams birth weight.|
|- Scientific Title||Study Towards the Effects of Post discharge nutrition on growth and body composition of infants born <= 32 weeks gestation and/or <= 1500 grams birth weight.|
|- hypothesis||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.
|- Healt Condition(s) or Problem(s) studied||Growth retardation, Body composition|
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-aug-2003|
|- planned closingdate||1-sep-2009|
|- Target number of participants||150|
|- Interventions||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.
|- 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;
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Drs. E.M. Amesz|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. H.N. Lafeber|
|- Sponsor/Initiator ||VU University Medical Center, Department of Paediatrics and Neonatology|
(Source(s) of Monetary or Material Support)
|Friesland Foods, Departement of Research and Development, Leeuwarden, the Netherlands|
|- Publications||Publications: Amesz EA, Schaafsma A, Cranendonk A, Lafeber HN. Optimal growth and lower fat mass in preterm infants fed a protein-enriched postdischarge formula. JPGN 2010;50:200-207.
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.
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||21-jul-2005 - 14-jun-2011|