Common Infant Feeding Problems Clinical Trial
Official title:
The Evaluation of Infant Formulas Fed to Infants With Common Feeding Problems
| Verified date | August 2013 |
| Source | Mead Johnson Nutrition |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 296 |
| Est. completion date | June 1996 |
| Est. primary completion date | June 1996 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 12 Weeks |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
| Country | Name | City | State |
|---|---|---|---|
| Canada | Dr. David Conner | Winnipeg | Manitoba |
| United States | Dr. Mark Pearlman | Aurora | California |
| United States | Kentucky Pediatrics | Bardstown | Kentucky |
| United States | Kids Med South | Baton Rouge | Louisiana |
| United States | Chapel Hill Pediatrics | Durham | North Carolina |
| United States | Welborn Clinic Peds | Evansville | Indiana |
| United States | Henderson Pediatrics | Fletcher | North Carolina |
| United States | Pediatric Medical Associates | Havertown | Pennsylvania |
| United States | Riveria Pediatrics | Indianapolis | Indiana |
| United States | Matthews Children Group | Matthews | North Carolina |
| United States | Gould Medical Foundation | Modesto | California |
| United States | The Pediatric Group | Princeton | New Jersey |
| United States | Capital Pediatrics | Raleigh | North Carolina |
| United States | Rhinelander Medical Center | Rhinelander | Wisconsin |
| United States | Lewis Gale Clinic | Salem | Virginia |
| United States | Memorial Medial Center Research | Savannah | Georgia |
| United States | Pennridge Pediatrics | Sellersville | Pennsylvania |
| United States | Pittsburgh Pediatric Research | Upper St. Clair | Pennsylvania |
| United States | Vancouver Clinic | Vancouver | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Mead Johnson Nutrition |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Early Infant Temperament Questionnaire | 14 days | No | |
| Secondary | Infant Characteristic Questionnaire | 14 days | No | |
| Secondary | Maternal Efficacy Questionnaire | 14 days | No | |
| Secondary | Mental Health Inventory Questionnaire | 14 days | No |