No registrations found.
ID
Source
Brief title
Health condition
(non-) organic growth failure
Sponsors and support
Intervention
Outcome measures
Primary outcome
Increase in Z-score for length at 6 weeks relative to baseline.
Secondary outcome
Anthropometrics, gastrointestinal tolerance, fecal microbiology and dietary intake.
Background summary
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.
Study objective
A nutrient dense infant formula promotes growth more effectively than current practice.
Study design
Baseline, and follow up measurements at 3 weeks, 6 weeks (and 9 weeks and 12 weeks, in case of optional extension period) after baseline.
Intervention
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.
PO Box 7005
Mieke Roelofs
Wageningen 6700 CA
The Netherlands
+31 (0)317 467 884
Mieke.Roelofs@numico-research.nl
PO Box 7005
Mieke Roelofs
Wageningen 6700 CA
The Netherlands
+31 (0)317 467 884
Mieke.Roelofs@numico-research.nl
Inclusion criteria
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.
Exclusion criteria
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.
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 | NL1156 |
| NTR-old | NTR1199 |
| Other | Numico Research B.V. : 100.153 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |