Growth and Tolerance of Young Infants

Abbott

Status

Completed

Conditions

Growth

Treatments

Other: Experimental Infant Formula

Other: Control Infant Formula

Study type

Interventional

Funder types

Industry

Identifiers

AL23

Details and patient eligibility

About

To compare growth and tolerance of healthy term infants fed two amino acid-based infant formulas.

Enrollment

267 patients

Sex

All

Ages

Under 8 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subject is judged to be in good health.
Singleton from a full-term birth with a gestational age of 37 - 42 weeks.
Birth weight was ≥ 2490 g (~5 lbs. 8 oz.).
Subject is between 0 and 8 days of age at enrollment.
Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D-containing supplements), solid foods or juices to their infant from enrollment through the duration of the study.
Subject's parent(s) has voluntarily signed and dated an ICF prior to any participation in the study.

Exclusion criteria

An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
Subject is taking and plans to continue medications, home remedies, herbal preparations, prebiotics, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance.
Subject participates in another study that has not been approved as a concomitant study.