Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants

ByHeart

Status: Completed

Conditions: Healthy; Term Infants

Treatments: Other: Study Formula (SF); Other: Comparator Formula (CF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04389606

SS-101-Follow-up

Details and patient eligibility

About

The purpose of this two-month follow-up study is to continue to follow growth, safety, and other health outcomes of infants fed a new infant formula for term infants or comparator formula. A reference group of human milk-fed infants will also be followed. This study is designed in accordance with Good Clinical Practice guidelines.

Enrollment: 311 patients

Sex: All

Ages: 16 to 19 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who enrolled and completed the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"

Exclusion criteria

• Subjects who did not enroll in the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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311 participants in 3 patient groups

Study Formula (SF)

Experimental group

Description:

New infant formula for term infants

Treatment:

Other: Study Formula (SF)

Other: Comparator Formula (CF)

Comparator Formula (CF)

Active Comparator group

Description:

Commercially available infant formula for term infants

Treatment:

Other: Study Formula (SF)

Other: Comparator Formula (CF)

Human Milk Reference Group

No Intervention group

Description:

Human milk