The Evaluation of Infant Formulas Fed to Infants With Common Feeding Problems

Not Applicable

Completed

• Conditions: Common Infant Feeding Problems
• Interventions: Other: Marketed milk-based lactose-containing infant formula; Other: Marketed milk-based lactose-free infant formula; Other: Marketed soy-based lactose-free infant formula

• Registration Number: NCT01934257
• Lead Sponsor: Mead Johnson Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1994-06
• Primary Completion: 1996-06
• Study Completion: 1996-06
• Status Verified: 2013-08
• Study First Submitted: 2013-08-27
• Study First Submitted QC: 2013-08-29
• Last Update Submitted: 2013-08-29
• Study First Posted: 2013-09-04
• Last Update Posted: 2013-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 296

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Marketed milk-based lactose-containing infant formula	Marketed milk-based lactose-containing infant formula	-
Marketed milk-based lactose-free infant formula	Marketed milk-based lactose-free infant formula	-
Marketed soy-based lactose-free infant formula	Marketed soy-based lactose-free infant formula	-

Primary Outcome Measures

Name	Time	Method
Early Infant Temperament Questionnaire	14 days

Secondary Outcome Measures

Name	Time	Method
Infant Characteristic Questionnaire	14 days
Maternal Efficacy Questionnaire	14 days
Mental Health Inventory Questionnaire	14 days

Trial Locations

Locations (19)

Riveria Pediatrics; 🇺🇸 Indianapolis, Indiana, United States

Dr. Mark Pearlman; 🇺🇸 Aurora, California, United States

Gould Medical Foundation; 🇺🇸 Modesto, California, United States

Welborn Clinic Peds; 🇺🇸 Evansville, Indiana, United States

Memorial Medial Center Research; 🇺🇸 Savannah, Georgia, United States

Kentucky Pediatrics; 🇺🇸 Bardstown, Kentucky, United States

The Pediatric Group; 🇺🇸 Princeton, New Jersey, United States

Kids Med South; 🇺🇸 Baton Rouge, Louisiana, United States

Chapel Hill Pediatrics; 🇺🇸 Durham, North Carolina, United States

Henderson Pediatrics; 🇺🇸 Fletcher, North Carolina, United States

Matthews Children Group; 🇺🇸 Matthews, North Carolina, United States

Capital Pediatrics; 🇺🇸 Raleigh, North Carolina, United States

Pediatric Medical Associates; 🇺🇸 Havertown, Pennsylvania, United States

Pennridge Pediatrics; 🇺🇸 Sellersville, Pennsylvania, United States

Lewis Gale Clinic; 🇺🇸 Salem, Virginia, United States

Pittsburgh Pediatric Research; 🇺🇸 Upper St. Clair, Pennsylvania, United States

Vancouver Clinic; 🇺🇸 Vancouver, Washington, United States

Rhinelander Medical Center; 🇺🇸 Rhinelander, Wisconsin, United States

Dr. David Conner; 🇨🇦 Winnipeg, Manitoba, Canada