Growth and Tolerance of Young Infants Fed Infant Formula

Growth and Tolerance Clinical Trial

Official title:

Growth and Tolerance of Young Infants Fed Milk-Based Infant Formula With Oligosaccharides

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04105686
• Other study ID #: AL31A
• Status: Completed
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: December 4, 2020

Study information

• Verified date: January 2021
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, multicenter, controlled, double-blind, parallel study to evaluate growth and tolerance of healthy term infants fed milk-based infant formulas.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: December 4, 2020
• Est. primary completion date: December 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Days

Eligibility

Inclusion Criteria:

• Participant is judged to be in good health as determined from participant's medical history.

• Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks.

• Participant's birth weight was > 2490 g (~5 lbs. 8 oz.).

• Parent(s) who elect to formula-feed the participant, confirm their intention to feed their infant the study product as the sole source of feeding during the study.

• Parent(s) who elect to feed the participant human milk, confirm their intention to exclusively feed human milk as the sole source of feeding during the study.

• Parent(s) of formula-fed infants confirm their intention not to administer vitamin or mineral supplements, (except for vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study.

• Parent(s) of human milk-fed infants confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study (vitamins and minerals are acceptable).

• Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria:

• An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.

• Participant is taking and plans to continue taking medications (including over the counter), prebiotics, probiotics, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance.

• Participant participates in another study that has not been approved as a concomitant study.

Related Conditions & MeSH terms

• Growth and Tolerance

Intervention

Other:
• Control Infant Formula
Ready to feed infant formula, feed ad libitum
• Experimental Infant Formula
Ready to feed infant formula, feed ad libitum

Locations

Country	Name	City	State
United States	TOPAZ Clinical Research, Inc.	Apopka	Florida
United States	Meridian Clinical Research 3080	Baton Rouge	Louisiana
United States	Gadolin Research, LLC	Beaumont	Texas
United States	Central Research Associates	Birmingham	Alabama
United States	Tekton Research	Chamblee	Georgia
United States	ClinOhio Research Services	Columbus	Ohio
United States	Ohio Pediatric Research Association	Dayton	Ohio
United States	PriMed Clinical Research	Dayton	Ohio
United States	University Clinical Research-Deland, LLC dba Avail Clinical Research- West Volusia Pediatrics	DeLand	Florida
United States	Southeastern Pediatric Associates	Dothan	Alabama
United States	Women's Hospital at Renaissance - Doctors Hospital at Renaissance	Edinburg	Texas
United States	Deaconess Clinic, Inc.	Evansville	Indiana
United States	Mercury Clincial Research, Inc.	Houston	Texas
United States	Children's Research, LLC	Lake Mary	Florida
United States	Wake Research - Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Applied Research Center of Arkansas	Little Rock	Arkansas
United States	DCOL Center for Clinical Research	Longview	Texas
United States	Medical Research Center of Memphis	Memphis	Tennessee
United States	Midsouth Center for Clinical Research	Memphis	Tennessee
United States	Institute of Clinical Research, LLC	Mentor	Ohio
United States	New Horizon Research Center	Miami	Florida
United States	The Cleveland Pediatric Research Center, LLC	Middleburg Heights	Ohio
United States	Saltzer Health	Nampa	Idaho
United States	Meridan Clinical Research	Omaha	Nebraska
United States	Aspen Clinical Research LLC	Orem	Utah
United States	Pediatric & Adult Research Center	Orlando	Florida
United States	Springs Medical Research	Owensboro	Kentucky
United States	Score Physician Alliance, LLC	Saint Petersburg	Florida
United States	Asclepes Research Centers	Spring Hill	Florida
United States	MultiCare Institute for Research and Innovation	Tacoma	Washington
United States	PAS Research, LLC	Tampa	Florida
United States	Visions Clinical Research	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
Other	Infant and Household Characteristics	Parent reported lifestyle and illness questions	Study Day 1 to Day of Life 119
Other	Infant Feeding and Stool Patterns Questionnaire	Parent completed questionnaire; 16, 5-point Likert scale questions, scaled in the negative direction	Exit or Day of life 119
Other	Infant Behavior Questionnaire	Parent completed questionnaire; 22 questions with 5-point Likert scale questions, scaled in the negative direction	Exit or Day of life 42 to Day of life 119
Other	Formula Satisfaction Questionnaire	Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled in the negative direction	Exit or Day of life 119
Primary	Weight	Weight gain per day	Day of life 14 to Day of life 119
Secondary	Stool Characteristics	Parent completed diary	Study Day 1 to Day of life 119
Secondary	Formula Tolerance	Parent completed diary	Study Day 1 to Day of life 119
Secondary	Length	Length gain per day	Day of life 14 to Day of life 119
Secondary	Head Circumference (HC)	HC gain per day	Day of life 14 to Day of life 119