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Single arm, open label, multi-centre intervention trial to evaluate the tolerance and acceptability of a high energy, nutrient enriched infant formula.


- candidate number14000
- NTR NumberNTR3708
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-nov-2012
- Secondary IDsITI.9.C/B/0 Danone Research Centre for Specialised Nutrition
- Public TitleSingle arm, open label, multi-centre intervention trial to evaluate the tolerance and acceptability of a high energy, nutrient enriched infant formula.
- Scientific TitleSingle arm, open label, multi-centre intervention trial to evaluate the tolerance and acceptability of a high energy, nutrient enriched infant formula.
- ACRONYMSATIN study
- hypothesisThere 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.
- Healt Condition(s) or Problem(s) studiedMalnutrition, Failure to thrive
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-nov-2012
- planned closingdate1-dec-2012
- Target number of participants20
- InterventionsDuring 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.
- Primary outcomeTolerance and acceptability.
- Secondary outcomeSafety parameters:
1. Occurrence of (serious) adverse events.
Other parameters:
2. Compliance (daily current and new formula intake);
3. Convenience (convenience questionnaire).
- TimepointsV1 ( Day -2) and V2 (Day 8).
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Willemien Sinke
- CONTACT for SCIENTIFIC QUERIES Annemiek Goedhart
- Sponsor/Initiator Nutricia Research Centre for Specialised Nutrition
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research - Centre for Specialised Nutrition
- PublicationsN/A
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD16-nov-2012 - 6-dec-2012


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