The test product supports normal physical growth in healthy term infants
ID
Bron
Verkorte titel
Aandoening
- Overige aandoening
Betreft onderzoek met
Ondersteuning
Onderzoeksproduct en/of interventie
- Voedingsstoffen/Voedingsmiddelen
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome is weight gain (grams per day) [Time frame: enrollment to 16 weeks of intervention]
Achtergrond van het onderzoek
This is a randomized, controlled, double blind study to evaluate the physical growth of healthy term infants fed an Investigational product compared to a commercially available infant formula that will act as a control. The primary outcome of this trial is weight gain per day during a 16 week intervention period. Main secondary outcomes are evaluation of gastrointestinal tolerance and the anthropometrical outcomes length and head circumference (both defined as: gain in cm/day).
Doel van het onderzoek
The test product supports normal physical growth in healthy term infants
Onderzoeksopzet
V1 (screening); V2 (2 weeks after V1); V3 (4 weeks after V1); V4 (8 weeks after V1), V5 (12 weeks after V1), V6 (16 weeks after V1)
Onderzoeksproduct en/of interventie
Intervention group: cow’s milk-based nutritionally complete infant formula. Control group: commercially available cow’s milk-based nutritionally complete infant formula.
Publiek
Wetenschappelijk
Landen waar het onderzoek wordt uitgevoerd
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Healthy, singleton, term born infants with gestational age of 37 – 42 weeks. 2. Infants aged ≤ 14 days at enrollment. 3. Birth weight within 10th to 90th percentile per gestational age and sex, according to Intergrowth Standards. 4. Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study. 5. Written informed consent (IC) from parent(s) and/or legal guardian(s) aged ≥18 years at screening.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Infants known or suspected to have cow's milk allergy, fish protein allergy, soy allergy and/or lactose intolerance. 2. Infants with current or previous illnesses/conditions which could interfere with the study outcomes, as assessed by the investigator. 3. Infants with previous, current or intended participation in any other clinical study involving investigational or marketed products.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
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 | NL9210 |
| Ander register | Advarra IRB : Pro00047197 |