"Watch Your Baby Grow" Study (GRO)

This study is currently recruiting participants.
Verified October 2013 by Monell Chemical Senses Center
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
ClinicalTrials.gov Identifier:
NCT01700205
First received: October 2, 2012
Last updated: October 23, 2013
Last verified: October 2013

October 2, 2012
October 23, 2013
October 2012
March 2017   (final data collection date for primary outcome measure)
Growth and energy balance [ Time Frame: Infant age 2 weeks to 18 months ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01700205 on ClinicalTrials.gov Archive Site
  • Intake and feeding behaviors [ Time Frame: Infant age 2 weeks to 18 months ] [ Designated as safety issue: No ]
    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.
  • Genotype [ Time Frame: 2wks-18 months ] [ Designated as safety issue: No ]
    Saliva and stool samples will be collected and later genotyped.
Same as current
Not Provided
Not Provided
 
"Watch Your Baby Grow" Study
Impact of Diet Composition on Energy Balance and Satiety During Infancy

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
  • Growth
  • Energy Balance
Other: Type of Formula
infant formula
Other Names:
  • cow milk formula (CMF)
  • protein hydrolysate formula (ePHF)
  • Active Comparator: Type of Formula: CMF
    infant is randomized to feed standard cow milk formula during first year of life
    Intervention: Other: Type of Formula
  • Experimental: Type of Formula: ePHF
    infant is randomized to feed extensively hydrolyzed infant formula during first year of life
    Intervention: Other: Type of Formula

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
144
December 2017
March 2017   (final data collection date for primary outcome measure)

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.
Both
up to 3 Weeks
Yes
Contact: Julie A Mennella, PhD 267-519-4880 mennella@monell.org
Contact: Loma Inamdar, BS 267-519-4896 linamdar@monell.org
United States
 
NCT01700205
HD072307
No
Julie A. Mennella, Monell Chemical Senses Center
Monell Chemical Senses Center
  • University of Delaware
  • Children's Hospital of Philadelphia
  • University of Wisconsin, Madison
Principal Investigator: Julie A Mennella, PhD Monell Chemical Senses Center
Principal Investigator: Jillian Trabulsi, PhD University of Delaware
Monell Chemical Senses Center
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP