(non-) organic growth failure
Conditions
Interventions
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
Sponsors
Numico Research B.V.
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in Z-score for length at 6 weeks relative to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Anthropometrics, gastrointestinal tolerance, fecal microbiology and dietary intake. | — |
Contacts
Public ContactMieke Roelofs
Numico Research B.V. PO Box 7005
Outcome results
None listed