Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants

ByHeart

Status: Completed

Conditions: Newborn; Infants

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04218929

SS-101-18

Details and patient eligibility

About

The purpose of this study is to demonstrate that a new infant formula for term infants supports age-appropriate growth. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary efficacy objective is to compare the growth of infants randomized to the study infant formula (SF) versus growth of infants randomized to the standard commercial infant formula (CF).

Enrollment: 311 patients

Sex: All

Ages: Under 14 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Term (no less than 37 weeks, 0 days and less than 42 weeks, 0 days), singleton infant.
• Birth weight of greater than or equal to 2500 grams.
• Designated healthy by a physician.
• Less than or equal to 14 days of age at enrollment.
• If formula fed, exclusively consuming and tolerating a cow's milk infant formula at enrollment and have a parent who agrees to feed the study formula as a sole source of nutrition for a minimum of 16 weeks.
• If human milk fed, predominantly consuming and tolerating human milk and have a mother/parent who plans to predominantly feed human milk as sole source of nutrition for a minimum of 16 weeks.
• Weight for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
• Length for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
• Head circumference for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
• Weight for length greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
• Not currently receiving and have a parent/guardian who does not plan to give pre- and/or pro-biotics for the full duration of the study.
• Not currently participating in an interventional clinical trial and have a parent(s) or legal guardian(s) who agree not to enroll the infant in an interventional clinical trial while participating in this trial.
• Have parent(s) or legal guardian(s) who are capable of completing the written records, questionnaires, and study procedures required by the protocol.
• Have a parent(s) or legal guardian(s) who have read and voluntarily signed the Institutional Review Board Informed Consent prior to study participation.

Exclusion criteria

• Evidence of any anatomic or physiologic condition that would interfere with normal growth, development, or feeding.
• Infants required to take medications know to influence growth and development.
• Maternal history with known adverse effects on the fetus and/or the newborn infants.
• Family history of cow milk protein allergy or soy intolerance/allergy.
• Infants receiving any amount supplemental human milk with infant formula or visa-versa at time of enrollment.
• Infants from a multiple birth.

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)

Comparator Formula (CF)

Active Comparator group

Description:

Commercially available infant formula for term infants

Treatment:

Other: Comparator Formula (CF)

Human Milk Reference Group

No Intervention group

Description:

Human milk