NCT03276884

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
267

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 11, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2018

Completed
Last Updated

December 3, 2018

Status Verified

November 1, 2018

Enrollment Period

1.1 years

First QC Date

September 7, 2017

Last Update Submit

November 30, 2018

Conditions

Growth

Outcome Measures

Primary Outcomes (1)

  • Weight Gain

    Infant scale

    Study Day 14 to Study Day 119

Secondary Outcomes (4)

  • GI tolerance

    Study Day 1 to Study Day 119

  • Length

    Study Day 1 to Study Day 119

  • Head Circumference

    Study Day 1 to Study Day 119

  • Weight

    Study Day 1 to Study Day 119

Study Arms (2)

Experimental Infant Formula

EXPERIMENTAL

Infant formula powder to be fed ad libitum

Other: Experimental Infant Formula

Control Infant Formula

ACTIVE COMPARATOR

Infant formula powder to be fed ad libitum

Other: Control Infant Formula

Interventions

Experimental Infant FormulaOTHER

amino acid-based infant formula powder

Experimental Infant Formula
Control Infant FormulaOTHER

amino acid-based infant formula powder

Control Infant Formula

Eligibility Criteria

AgeUp to 8 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

Southeastern Pediatric Associates

Dothan, Alabama, 36305, United States

Location

Watching Over Mothers and Babies

Tucson, Arizona, 85712, United States

Location

The Children's Clinic of Jonesboro, P.A.

Jonesboro, Arkansas, 72401, United States

Location

Norwich Pediatric Group, PC

Norwich, Connecticut, 06360, United States

Location

Children's Research, LLC

Lake Mary, Florida, 32746, United States

Location

Score Physician Alliance, LLC

St. Petersburg, Florida, 33710, United States

Location

Saltzer Medical Group

Nampa, Idaho, 83686, United States

Location

Deaconess Clinic, Inc.

Evansville, Indiana, 47713, United States

Location

Springs Medical Research

Owensboro, Kentucky, 42303, United States

Location

Women's Clinic of Lincoln, PC

Lincoln, Nebraska, 68510, 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

Medical Research South

Charleston, South Carolina, 29407, United States

Location

Coastal Pediatric Research 3002

Charleston, South Carolina, 29414, United States

Location

Coastal Pediatric Associates 3004

Mt. Pleasant, South Carolina, 29464, United States

Location

Coastal Pediatric Research 3003

North Charleston, South Carolina, 29406, United States

Location

Memphis & Shelby County Pediatric Group

Memphis, Tennessee, 38116, United States

Location

Vilo Research Group Inc

Houston, Texas, 77017, United States

Location

Southwest Children's Research Associates, PA

San Antonio, Texas, 78229, United States

Location

Tanner Clinic

Layton, Utah, 84041, United States

Location

Study Officials

  • Jan Kajzer, MS, RD, LD

    Abbott Nutrition

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 8, 2017

Study Start

October 11, 2017

Primary Completion

November 8, 2018

Study Completion

November 8, 2018

Last Updated

December 3, 2018

Record last verified: 2018-11

Locations

US(22)