No registrations found.
ID
Source
Brief title
Health condition
malnutrition, failure to thrive
Sponsors and support
Intervention
Outcome measures
Primary outcome
Tolerance and acceptability.
Secondary outcome
Safety parameters:
1. Occurrence of (serious) adverse events.
Other parameters:
2. Compliance (daily current and new formula intake);
3. Convenience (convenience questionnaire).
Background summary
In this trial the tolerance and acceptability of a new high energy, nutrient enriched infant formula will be evaluated in children receiving the current high energy, nutrient enriched infant formula.
Study objective
There will be no issues with regards to tolerance in relation to the switch from the current to the new high energy, nutrient enriched infant formula.
Study design
V1 ( Day -2) and V2 (Day 8).
Intervention
During a 3-days baseline period subjects will receive the current high energy, nutrient enriched infant formula. GI symptoms, stool frequency, stool consistency and the amount of current formula consumed will be recorded on a daily basis in a diary. During the following 7-day intervention period subjects will consume the study formula (new high energy, nutrient enriched infant formula). GI symptoms, stool frequency, stool consistency and the amount of study formula consumed will be recorded on a daily basis in a diary.
Bosrandweg 20
Willemien Sinke
Wageningen 6704 PH
The Netherlands
+31 (0)317 467955
willemien.sinke@nutricia.com
Bosrandweg 20
Willemien Sinke
Wageningen 6704 PH
The Netherlands
+31 (0)317 467955
willemien.sinke@nutricia.com
Inclusion criteria
1. Age 0 to 18 months (including 0 and 18 months);
2. 37 to 42 weeks gestation at birth;
3. Currently receiving a high energy, nutrient enriched infant formula (current Infatrini) for at least 7 days prior to the baseline visit (day -2);
4. Expected to require a high energy infant formula for at least 10 days after baseline visit;
5. Consuming, on average, at least 50% of their energy intake from the study feed;
6. Either enterally fed (naso-enteric tube, gastrostomy, jejunostomy) or orally fed (bottle fed);
7. Written informed consent from parents/ guardians that have legal custody of the child;
8. Parents/ guardians should have good knowledge of Dutch language.
Exclusion criteria
1. Body weight > 9kg;
2. Proven cow‟s milk allergy;
3. Lactose intolerance;
4. Galactosaemia;
5. Other medical or dietary contraindication to a polymeric, high energy, nutrient enriched infant formula (eg major hepatic or renal dysfunction);
6. BMR vaccination performed within 14 days prior to baseline visit, any other vaccination performed within 48 hours prior to baseline visit or any vaccination planned within 10 days after baseline visit;
7. Any surgery planned within 10 days after baseline visit;
8. Investigator's uncertainty about the willingness or ability of the parent/caregiver to comply with the protocol requirements;
9. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the 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 | NL3524 |
NTR-old | NTR3708 |
Other | Danone Research – Centre for Specialised Nutrition : ITI.9.C/B/0 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |