Clinical trial NCT01934257: The Evaluation of Infant Formulas Fed to Infants With Common Feeding Problems
Official title: The Evaluation of Infant Formulas Fed to Infants With Common Feeding Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Infant Feeding Problems
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2013-09-04
Enrollment: 296
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This clinical trial will determine if the formula given to infants experiencing fussiness, crying, cramping, gas, and/or diarrhea, is accepted and well tolerated and helps to resolve symptoms.


Eligibility criteria: Inclusion Criteria:

* Subject is between 2 and 12 weeks of age
* Subject has currently been receiving a milk-based lactose-containing formula for at least 5 days as the sole item of diet
* Subject has never switched to any lactose free formula
* The parent/guardian who will fill out the quality of life questionnaire is female and at least 18 years of age
* The parent/guardian has reported an unsolicited history of feeding problems including fussiness/crying/cramping, gas, or diarrhea
* Signed Informed Consent

Exclusion Criteria:

* Subject is in daycare for more than 4 hours per day (20 hours per week)
* Subject has serious perinatal complications, underlying disease or congenital malformations that impair normal formula feeding
* The parent/guardian who will fill out the quality of life questionnaire has chronic illness, e.g. diabetes, inflammatory bowel disease or other illness requiring daily medication or treatment
* Subject has acute infectious diarrhea or any other intercurrent illness

Primary outcomes:
measure: Early Infant Temperament Questionnaire
timeFrame: 14 days
Secondary outcomes:
measure: Infant Characteristic Questionnaire
timeFrame: 14 days
measure: Maternal Efficacy Questionnaire
timeFrame: 14 days
measure: Mental Health Inventory Questionnaire
timeFrame: 14 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Dr. Mark Pearlman
state: California
city: Modesto
country: United States
facility: Gould Medical Foundation
state: California
city: Savannah
country: United States
facility: Memorial Medial Center Research
state: Georgia
city: Evansville
country: United States
facility: Welborn Clinic Peds
state: Indiana
city: Indianapolis
country: United States
facility: Riveria Pediatrics
state: Indiana
city: Bardstown
country: United States
facility: Kentucky Pediatrics
state: Kentucky
city: Baton Rouge
country: United States
facility: Kids Med South
state: Louisiana
city: Princeton
country: United States
facility: The Pediatric Group
state: New Jersey
city: Durham
country: United States
facility: Chapel Hill Pediatrics
state: North Carolina
city: Fletcher
country: United States
facility: Henderson Pediatrics
state: North Carolina
city: Matthews
country: United States
facility: Matthews Children Group
state: North Carolina
city: Raleigh
country: United States
facility: Capital Pediatrics
state: North Carolina
city: Havertown
country: United States
facility: Pediatric Medical Associates
state: Pennsylvania
city: Sellersville
country: United States
facility: Pennridge Pediatrics
state: Pennsylvania
city: Upper St. Clair
country: United States
facility: Pittsburgh Pediatric Research
state: Pennsylvania
city: Salem
country: United States
facility: Lewis Gale Clinic
state: Virginia
city: Vancouver
country: United States
facility: Vancouver Clinic
state: Washington
city: Rhinelander
country: United States
facility: Rhinelander Medical Center
state: Wisconsin
city: Winnipeg
country: Canada
facility: Dr. David Conner
state: Manitoba
Study officials:
affiliation: Mead Johnson & Company
name: Colin Rudolph, M.D., Ph.D
role: STUDY_DIRECTOR
References:
citation: Sherman AL, Anderson J, Rudolph CD, Walker LS. Lactose-Free Milk or Soy-Based Formulas Do Not Improve Caregivers' Distress or Perceptions of Difficult Infant Behavior. J Pediatr Gastroenterol Nutr. 2015 Jul;61(1):119-24. doi: 10.1097/MPG.0000000000000743.