A randomised, controlled, double-blind trial to investigate the effects of a new infant formula on growth, tolerance and safety in healthy term infants.

A randomised, controlled, double-blind trial to investigate the effects of a new infant formula on growth, tolerance and safety in healthy term infants. - Mercurius

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39783

Enrollment

124

Registered

2012-11-20

Start date

2014-12-16

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

effect op de groei van zuigelingen effects on growth

Interventions

Infants who will be randomised equally to the following groups: - Test group: receiving test product - Control group: receiving control product Infants who are exclusively breastfed and whose mothe

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Healthy term infants (gestational age >= 37 1/7 and

Exclusion criteria

Exclusion criteria: - Infants known to have current or previous illnesses/conditions or intervention which could interfere with the study or its outcome parameters, such as gastrointestinal malformations, congenital metabolic disorders, immune deficiency or major surgery, as per investigator*s clinical judgement - Infants whose mother is known to suffer from hepatitis B or human immunodeficiency virus (HIV)

Design outcomes

Primary

Measure	Time frame
Weight gain in grams per day from randomisation until 17 weeks of age [g/day].	—

Secondary

Measure	Time frame
Gain from randomisation until 17 weeks of age of: - Recumbent length [mm/day] - Head circumference [mm/day] - Mid-upper arm circumference [mm/day] - Skin folds (subscapular, triceps) [mm/day]. Total weight gain in gram from randomization until 12 months of age [g/day]. Gain from randomization until 12 months of age of: Recumbent length [mm/day] - Head circumference [mm/day] - Mid-upper arm circumference [mm/day] - Skin folds (subscapular, triceps) [mm/day]. Sum of skin folld thickness: triceps, biceps, suprilliac, subscapular [mm/day]. Z-scores of anthropometric parameters until 17 weeks and 12 months of age: - Weight-for-age z-scores - Weight-for-length z-scores - Length-for-age z-scores - BMI-for-age z-scores - Head circumference-for-age z-scores - Mid-upper arm circumference-for-age z-scores - Skinfold-for-age z-scores (subscapular, triceps) Number, type and severity of (serious) adverse events Use of medication and nutritional supplements Gastrointestinal tolerance parameters utnil 17 weeks of age (via a diary) including: - Occurrence and severity of gastrointestinal symptoms (cramps, diaper/nappy rash, regurgitation, and vomiting) - Stool frequency - Stool consistency - Occurrence of diarrhoea and constipation.	—

Measure

Time frame

Gain from randomisation until 17 weeks of age of: - Recumbent length [mm/day] - Head circumference [mm/day] - Mid-upper arm circumference [mm/day] - Skin folds (subscapular, triceps) [mm/day]. Total weight gain in gram from randomization until 12 months of age [g/day]. Gain from randomization until 12 months of age of: Recumbent length [mm/day] - Head circumference [mm/day] - Mid-upper arm circumference [mm/day] - Skin folds (subscapular, triceps) [mm/day]. Sum of skin folld thickness: triceps, biceps, suprilliac, subscapular [mm/day]. Z-scores of anthropometric parameters until 17 weeks and 12 months of age: - Weight-for-age z-scores - Weight-for-length z-scores - Length-for-age z-scores - BMI-for-age z-scores - Head circumference-for-age z-scores - Mid-upper arm circumference-for-age z-scores - Skinfold-for-age z-scores (subscapular, triceps) Number, type and severity of (serious) adverse events Use of medication and nutritional supplements Gastrointestinal tolerance parameters utnil 17 weeks of age (via a diary) including: - Occurrence and severity of gastrointestinal symptoms (cramps, diaper/nappy rash, regurgitation, and vomiting) - Stool frequency - Stool consistency - Occurrence of diarrhoea and constipation.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)