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"Watch Your Baby Grow" Study (GRO)

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ClinicalTrials.gov Identifier: NCT01700205
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : December 18, 2017
Sponsor:
Collaborators:
University of Delaware
Children's Hospital of Philadelphia
University of Wisconsin, Madison
Information provided by (Responsible Party):
Julie A. Mennella, Monell Chemical Senses Center

Brief Summary:
The overarching goal of the research we propose here is to conduct a randomized clinical trial to specify the physiologic and behavioral mechanisms by which infant-formula composition affects all aspects of energy balance and growth during the first years of life.

Condition or disease Intervention/treatment Phase
Development Other: Type of Formula Not Applicable

Detailed Description:
This is a randomized clinical trial of infants whose parents decided to formula feed them; mother-infant dyads will be randomized when infant is 2 weeks of age to one of 2 groups. The groups will differ in the composition of the formula fed to the infant during the first year of life.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Official Title: Impact of Diet Composition on Energy Balance and Satiety During Infancy
Actual Study Start Date : October 2012
Actual Primary Completion Date : February 2016
Actual Study Completion Date : September 21, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Type of Formula: CMF
infant is randomized to feed standard cow milk formula during first year of life
Other: Type of Formula
infant formula
Other Names:
  • cow milk formula (CMF)
  • protein hydrolysate formula (EHF)

Experimental: Type of Formula: EHF
infant is randomized to feed extensively hydrolyzed infant formula during first year of life
Other: Type of Formula
infant formula
Other Names:
  • cow milk formula (CMF)
  • protein hydrolysate formula (EHF)




Primary Outcome Measures :
  1. Growth and energy balance [ Time Frame: Infant age 2 weeks to 18 months ]
    Anthropometry z-scores (weight for age, length for age, head circumference for age, weight for length) obtained during monthly assessments for first 18 mos of life. All components of energy balance measured at 0.5, 3, and 12 months


Secondary Outcome Measures :
  1. Intake and feeding behaviors [ Time Frame: Infant age 2 weeks to 18 months ]
    Intake and satiety behaviors measured during infant-led feeding conditions. Maternal reports of infant dietary history and maternal perception of infant behavior, using standardized questionnaires, will also be obtained.

  2. Genotype [ Time Frame: 2wks-18 months ]
    Saliva and stool samples will be collected and later genotyped.



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Ages Eligible for Study:   up to 3 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. A healthy, term (≥37 and ≤42 week gestation at birth), singleton infant.
  2. Birth weight between 2500 - 4500 grams.
  3. At the time of enrollment, infant must be ≤14 days old (Date of birth=day 0).
  4. Mother must be 18 years or older.
  5. Infant must be consuming a standard cow's milk protein infant formula and have been receiving a standard cow's milk protein infant formula for at least the past 2 days prior to enrollment.

Exclusion Criteria

  1. Mother had gestational diabetes during pregnancy
  2. Infant has condition requiring infant feedings other than feeding cow milk formula from a bottle.
  3. Infant has major congenital malformations (i.e. cleft palate, hemangiomas, extremity malformation).
  4. Infant has suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus).
  5. Infant has evidence of significant cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases. For example, infant must not be receiving insulin or growth hormone.
  6. Dyad be the relative (son, daughter, niece, nephew, cousin, aunt, uncle, sibling) of ancillary personnel connected with the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700205


Locations
United States, Pennsylvania
Monell Chemical Senses Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Monell Chemical Senses Center
University of Delaware
Children's Hospital of Philadelphia
University of Wisconsin, Madison
Investigators
Principal Investigator: Julie A Mennella, PhD Monell Chemical Senses Center
Principal Investigator: Jillian Trabulsi, PhD University of Delaware

Publications:
Responsible Party: Julie A. Mennella, Member, Monell Chemical Senses Center
ClinicalTrials.gov Identifier: NCT01700205     History of Changes
Other Study ID Numbers: HD072307
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017

Keywords provided by Julie A. Mennella, Monell Chemical Senses Center:
Formula Feeding
Mother
Moms
Infants
Babies
Baby
growth
energy balance