Study to investigate the nutritional efficacy and suitability of infant formulae in healthy full-term infants.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21301

Enrollment

156

Registered

2009-12-02

Start date

2009-12-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Healthy full-term infants

Interventions

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy full-term infants (gestational age > 37 and 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Secondary

Measure	Time frame
1. Recumbent length gain; 2. Increase in head circumference.	—

Primary

Measure	Time frame
Weight gain.	—

Contacts

Public ContactLilian van Tuyl

Uppsalalaan 12

lilian.van-tuyl@nutricia.com+31 (0)30 2095000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)