Human Milk Oligosaccharides (HMOs) Post-market Study on Infants

Launched by SOCIÉTÉ DES PRODUITS NESTLÉ (SPN) · Aug 12, 2019

Keywords

ClinConnect Summary

Objectives:

The main objective of this study is to document the growth and feeding tolerance of healthy term infants consuming an infant formula supplemented with HMOs for 8 weeks (56 days), in a real-world setting.

Main endpoints:

1. Growth documented via monitoring the anthropometric parameters including weight, length, head circumference, BMI and their corresponding z-scores (i.e., z-scores for weight-for-age, length-for-age, weight-for-length, head circumference-for-age, and BMI-for-age) calculated using the 2006 WHO Growth Standards
2. Feeding tolerance assessed via monitoring paren...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Evidence of personally signed and dated informed consent document indicating that the infant's parent(s) have been informed of all pertinent aspects of the study
• • 2. Parent(s) are willing and able to fulfill the requirements of the study protocol
• • 3. Healthy full term (37-42 weeks gestation) infant
• • 4. Be between post-natal age (Date of Birth = Day 0) 7 days to 2 months
• • 5. Parent(s) must have independently elected, before enrollment, to formula feed
• Exclusion Criteria:
• • 1. Evidence of personally signed and dated informed consent document indicating that the infant's parent(s) have been informed of all pertinent aspects of the study
• • 2. Parent(s) are willing and able to fulfill the requirements of the study protocol
• • 3. Healthy full term (37-42 weeks gestation) infant
• • 4. Be between post-natal age (Date of Birth = Day 0) 7 days to 2 months
• • 5. Infants must have been exclusively consuming breast milk since birth, and their parent(s) must have made the decision to continue exclusively breastfeeding until at least 4 month of age