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.
ID
Bron
Verkorte titel
Aandoening
malnutrition, failure to thrive
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Tolerance and acceptability.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
V1 ( Day -2) and V2 (Day 8).
Onderzoeksproduct en/of interventie
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.
Publiek
Bosrandweg 20
Willemien Sinke
Wageningen 6704 PH
The Netherlands
+31 (0)317 467955
willemien.sinke@nutricia.com
Wetenschappelijk
Bosrandweg 20
Willemien Sinke
Wageningen 6704 PH
The Netherlands
+31 (0)317 467955
willemien.sinke@nutricia.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL3524 |
NTR-old | NTR3708 |
Ander register | Danone Research – Centre for Specialised Nutrition : ITI.9.C/B/0 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |