A nutrient dense infant formula promotes growth more effectively than current practice.
ID
Bron
Verkorte titel
Aandoening
(non-) organic growth failure
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Increase in Z-score for length at 6 weeks relative to baseline.
Achtergrond van het onderzoek
The aim of this study is to compare the effects, with regard to growth, of a nutrient dense infant formula to the effect of current practice in Spain in infants requiring a high-energy feed. Therefore, subjects will receive either a nutrient dense infant formula or current practice for a period of 6 weeks. An optional 6-week extension period is offered to all subjects completing the initial 6-week study period. Baseline anthropometrics measurements will be collected and repeated outcomes will be measured during hospital visits at week 3, 6, 9, and 12. Tolerance to the feed will be recorded weekly and a 3-day food diary will be completed to evaluate the intake of other foods/drinks. Subject's blood and stool samples will be collected at baseline, 6 weeks, and 12 weeks for the analysis of safety parameters and fecal microbiota respectively.
Doel van het onderzoek
A nutrient dense infant formula promotes growth more effectively than current practice.
Onderzoeksopzet
Baseline, and follow up measurements at 3 weeks, 6 weeks (and 9 weeks and 12 weeks, in case of optional extension period) after baseline.
Onderzoeksproduct en/of interventie
Duration intervention: 6-12 weeks. Intervention group: a high energy, high protein and nutrient dense, nutritionally complete, ready-to-use feed for infants 0-12 months. Control group: constitutes all infant formulas used as part of "current practice" in Spain for infants with increased energy requirements and/or fluid restrictions.
Publiek
PO Box 7005
Mieke Roelofs
Wageningen 6700 CA
The Netherlands
+31 (0)317 467 884
Mieke.Roelofs@numico-research.nl
Wetenschappelijk
PO Box 7005
Mieke Roelofs
Wageningen 6700 CA
The Netherlands
+31 (0)317 467 884
Mieke.Roelofs@numico-research.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Infants aged 0 to 9 months;
2. Infants with increased energy requirements and/or fluid restrictions and/or with indication for using high-energy feeds;
3. The infants must be new consumers of oral high-energy feeds;
4. Infants must have an expected requirement for the study product for at least 6 weeks, with an expected study product intake of, on average, at least 50% of their energy intake;
5. Written parental informed consent must be available.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Infants with cow's milk intolerance, major gastrointestinal hepatic or renal dysfunction, or inherited metabolic disorders including galactosaemia are excluded for this study;
2. Investigator's uncertainty about the willingness or ability of the caretaker to comply with the protocol requirements;
3. Participation in any other studies with investigational or marketed products concomitantly or within two weeks prior to entry into this study.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1156 |
| NTR-old | NTR1199 |
| Ander register | Numico Research B.V. : 100.153 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |