The investigational formulae are equivalent to the currently marketed control formula with regard to weight gain of healthy full-term infants during first 16 weeks of life.
ID
Bron
Verkorte titel
Aandoening
Healthy full-term infants
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Weight gain.
Achtergrond van het onderzoek
This study aims to investigate the nutritional efficacy and suitability of two infant formulae with slightly modified composition in healthy full-term infants compared to a currently marketed infant formula primarily on weight gain in the first 16 weeks of life. A follow-up visit will take place at 52 weeks of life. During the intervention period parents will be asked to record gastrointestinal tolerance and formula intake. In a subgroup of infants (on a voluntary basis) a blood sample will be collected at the age of 16 weeks for nutritional status and safety.
Doel van het onderzoek
The investigational formulae are equivalent to the currently marketed control formula with regard to weight gain of healthy full-term infants during first 16 weeks of life.
Onderzoeksopzet
Screening, baseline, visits on 4, 8, 12, 16, and 52 weeks.
Onderzoeksproduct en/of interventie
Duration of intervention: 14-16 weeks.
Intervention groups: Two investigational formulae with slightly modified composition.
Control group: the control formula is a currently marketed infant formula.
Publiek
Lilian van Tuyl
Utrecht 3584 CT
The Netherlands
+31 (0)30 2095000
lilian.van-tuyl@nutricia.com
Wetenschappelijk
Lilian van Tuyl
Utrecht 3584 CT
The Netherlands
+31 (0)30 2095000
lilian.van-tuyl@nutricia.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Healthy full-term infants (gestational age > 37 and < 42 weeks, birth weight > 2.5 kg);
2. Infants with appropriate birth weight within normal range for gestational age and sex;
3. Infants aged <= 14 days at study entry;
4. Infants who are exclusively formula fed (mothers who have chosen not to breastfeed or mothers who ceased breastfeeding by time of inclusion);
5. Written informed consent from both parents.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Infants with birth weight > 4.5 kg;
2. Infants diagnosed with a congenital illness or malformation that could affect normal growth;
3. Infants with significant pre- or postnatal disease;
4. Infants that are already participating in another clinical trial;
5. Infants with cows' milk allergy, soy allergy or lactose intolerance.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2011 |
| NTR-old | NTR2128 |
| Ander register | Nutricia Research : All.3.C/A |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |