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NCT03276884 Clinical Trial

Growth and Tolerance of Young Infants

Growth Clinical Trial

Official title:
Growth and Tolerance of Young Infants Fed Amino Acid-Based Formulas

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03276884
Other study ID # AL23
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 11, 2017
Est. completion date November 8, 2018

Study information
Verified date November 2018
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 267
Est. completion date November 8, 2018
Est. primary completion date November 8, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 8 Days
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Experimental Infant Formula
amino acid-based infant formula powder
• Control Infant Formula
amino acid-based infant formula powder

Locations
Country Name City State
United States Alabama Clinical Therapeutics, LLC Birmingham Alabama
United States Coastal Pediatric Research 3002 Charleston South Carolina
United States Medical Research South Charleston South Carolina
United States Southeastern Pediatric Associates Dothan Alabama
United States Deaconess Clinic, Inc. Evansville Indiana
United States Pediatric Associates of Fairfield, Inc. Fairfield Ohio
United States Vilo Research Group Inc Houston Texas
United States The Children's Clinic of Jonesboro, P.A. Jonesboro Arkansas
United States Children's Research, LLC Lake Mary Florida
United States Tanner Clinic Layton Utah
United States Women's Clinic of Lincoln, PC Lincoln Nebraska
United States Memphis & Shelby County Pediatric Group Memphis Tennessee
United States Institute of Clinical Research, LLC Mentor Ohio
United States The Cleveland Pediatric Research Center, LLC Middleburg Heights Ohio
United States Coastal Pediatric Associates 3004 Mount Pleasant South Carolina
United States Saltzer Medical Group Nampa Idaho
United States Coastal Pediatric Research 3003 North Charleston South Carolina
United States Norwich Pediatric Group, PC Norwich Connecticut
United States Springs Medical Research Owensboro Kentucky
United States Score Physician Alliance, LLC Saint Petersburg Florida
United States Southwest Children's Research Associates, PA San Antonio Texas
United States Watching Over Mothers and Babies Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Weight Gain Infant scale Study Day 14 to Study Day 119
Secondary GI tolerance Parent completed questionnaires Study Day 1 to Study Day 119
Secondary Length Length board Study Day 1 to Study Day 119
Secondary Head Circumference Measure tape Study Day 1 to Study Day 119
Secondary Weight Infant scale Study Day 1 to Study Day 119
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