Infants Fed a Hydrolyzed Infant Formula

Tolerance of Infants Fed a Hydrolyzed Infant Formula

The purpose of this non-randomized, multi-center study is to evaluate the growth, tolerance and compliance of an extensively hydrolyzed infant formula in an intended use population of infants.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Tolerance
• Intervention / Treatment: Other: Hydrolyzed protein infant formula with oligosaccharides

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Meridian Clinical Research, LLC
  • Florida
    • Orange City, Florida, United States, 32763
      • AdventHealth Medical Group Pediatrics
  • Georgia
    • Fayetteville, Georgia, United States, 72703
      • Javara inc.
    • Macon, Georgia, United States, 31210
      • Meridian Clinical Research 3259
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Springs Medical Research
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Meridian Clinical Research 3357
  • Texas
    • Houston, Texas, United States, 77084
      • Gentle Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 2 months (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Infant is 0 to 90 days of age at enrollment.
• Formula-fed Infant who is either experiencing persistent feeding intolerance, symptoms of suspected food protein allergy or currently consuming an extensively hydrolyzed formula (EHF) for symptoms of suspected food protein allergy, persistent feeding intolerance symptoms or other conditions where EHF is deemed an appropriate feeding by their health care professional
• Parent(s) of infants confirm their intention not to administer prescription medications, OTC medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance, unless their infants are currently consuming and have been directed by their healthcare professional to continue their use during the study
• 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 solid foods or juices to their infant from enrollment through the duration of the study
• Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements) to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional
• Infant's parent(s) or a LAR has voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other 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 growth, and/or development
• Awareness of a positive drug screen in the mother or participant
• Suspected maternal substance abuse including alcohol
• Participation in another study that has not been approved as a concomitant study by AN
• Participant is receiving oral or inhaled steroids
• Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent
• Participant has received an amino acid-based formula

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Product; Infant formula product consumed ad libitum as instructed for approximately 28 days; Powder formula mixed to 20 kcal/fl. oz.	Other: Hydrolyzed protein infant formula with oligosaccharides; Hydrolyzed protein infant formula with oligosaccharides

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Maintenance	Change in weight for age z-score	Study Day1 to Study Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal Tolerance	Parent completed diary	Study Day1 to Study Day 28
Weight	Weight gain per day in grams	Study Day1 to Study Day 28
Length	Length gain per day in cm	Study Day1 to Study Day 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent Perspectives Questionnaire	Parent completed questionnaire; 4, 5-point Likert scale questions, scaled from negative to positive with higher scores indicating better perception	Study Day1 to Study Day 28
Formula Satisfaction Questionnaire	Parent completed questionnaire; 13 questions of up to 5 categories, scaled from positive to negative	Study Day1 to Study Day 28
Infant Feeding and Stool Patterns Questionnaire	Parent completed questionnaire; 16, 5-point Likert scale questions, scaled from always to never	Study Day1 to Study Day 28
Health Care Utilization	Number of Visits	Study Day1 to Study Day 28
Adverse Events	Parent reported adverse events	Study Day1 to Study Day 28

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Carlett Ramirez, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2022
• Primary Completion (Actual): June 23, 2023
• Study Completion (Actual): November 18, 2023

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AL49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No