Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas

NCT04006236 | Completed

• 1 other identifier: AL33
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 17

Brief Summary

This is a randomized, controlled, double-blind, multicenter parallel study to evaluate the growth, tolerance and compliance of healthy infants fed infant formulas with extensively hydrolyzed casein protein.

Conditions

Infant Development

Outcome Measures

Primary Outcomes (1)

• Weight

  Interval weight gain per day

  Day of Age (DOA) 14 to 119

Secondary Outcomes (4)

• Length

  Study Day (SD) 1 to DOA 119

• Head Circumference

  Study Day (SD) 1 to DOA 119

• Stool Characteristics

  Study Day (SD) 1 to DOA 119

• Formula Intake

  Study Day (SD) 1 to DOA 119

Other Outcomes (3)

• Infant Feeding and Stool Patterns Questionnaire

  Exit or DOA 119

• Infant Behavior Questionnaire

  Exit or DOA 119

• Formula Satisfaction Questionnaire

  Exit or DOA 119

Study Arms (2)

Experimental Infant Formula

EXPERIMENTAL

extensively hydrolyzed casein protein

Other: Experimental Infant Formula

Control Infant Formula

ACTIVE COMPARATOR

extensively hydrolyzed casein protein

Other: Control Infant Formula

Interventions

Experimental Infant Formula OTHER

Feed Ad Libitum

Experimental Infant Formula

Control Infant Formula OTHER

Feed Ad Libitum

Control Infant Formula

Eligibility Criteria

• Age: 0 Days - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participant is judged to be in good health
• 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) 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 vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment throughout the duration of the study
• Participant's parent(s) 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

You may not qualify if:

• 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, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
• Participant participates in another study that has not been approved as a concomitant study by AN.
• Participant has an allergy or intolerance to any ingredient in the study product
• Participant has been treated with antibiotics within 1 week prior to enrollment

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (17)

MedPharmics, LLC

Phoenix, Arizona, 85015, United States

Location

Watching Over Mothers & Babies

Tucson, Arizona, 85712, United States

Location

Paramount Research Solutions

College Park, Georgia, 30349, United States

Location

Springs Medical Research

Owensboro, Kentucky, 42303, United States

Location

MedPharmics, LLC

Metairie, Louisiana, 70006, United States

Location

MedPharmics, LLC

Gulfport, Mississippi, 30503, United States

Location

Quality Clinical Research Inc

Omaha, Nebraska, 68114, United States

Location

MedPharmics, LLC

Albuquerque, New Mexico, 87102, United States

Location

PMG Research of Peidmont Healthcare

Statesville, North Carolina, 28625, United States

Location

Pediatric Associates of Fairfield, Inc.

Fairfield, Ohio, 45014, United States

Location

Institute of Clinical Research, LLC

Mentor, Ohio, 44060, United States

Location

The Cleveland Pediatric Research Center, LLC

Middleburg Heights, Ohio, 44130, United States

Location

Children's Hospital

Sioux Falls, South Dakota, 57105, United States

Location

Midsouth Center for Clinical Research

Memphis, Tennessee, 38116, United States

Location

Ventavia Research Group, Llc

Fort Worth, Texas, 76104, United States

Location

Ventavia Research Group

Houston, Texas, 77008, United States

Location

Ventavia Research Group, LLC

Plano, Texas, 75093, United States

Location

Study Officials

• Carlett Ramirez

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: August 5, 2019
• Primary Completion: September 20, 2021
• Study Completion: September 20, 2021
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)