A safety and growth study with a new fat blend.

Completed

• Conditions: Healthy term infants

• Registration Number: NL-OMON21391
• Lead Sponsor: Danone Research – Centre for Specialised Nutrition

Brief Summary

1. Heijning, B.v.d., et al., 51st ESPGHAN Annual Meeting. Journal of Pediatric Gastroenterology and Nutrition, 2018. 66: p. 1110-1111. 2. Breij, L.M., et al., ESPGHAN 49th ANNUAL MEETING of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition. Journal of Pediatric Gastroenterology and Nutrition, 2016. 62: p. 867-868. 3. Breij, L.M., et al., An infant formula with large, milk phospholipid-coated lipid droplets containing a mixture of dairy and vegetable lipids supports adequate growth and is well tolerated in healthy, term infants. Am J Clin Nutr, 2019. 109(3): p. 586-596.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 313

Inclusion Criteria

1. Healthy term (gestational age >= 37 1/7 and <= 42 6/7 weeks);

2. Age <= 35 days (preferably as soon as possible after birth);

Exclusion Criteria

1. Known current or previous illnesses/conditions or intervention which could interfere with the study or its outcome parameters;

2. Mother known to suffer from hepatitis B or human immunodeficiency virus (HIV) with a minimum number of formula fed infants ≤ 14 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate equivalence of weight gain from randomisation until the age of 17 weeks.

Secondary Outcome Measures

Name	Time	Method
1. To investigate equivalence of other growth parameters until the age of 17 weeks.<br>2. To assess gastrointestinal tolerance and safety until the age of 17 weeks.<br>3.To investigate efficacy in weight gain at 12 months