Healthy, Full-term Infants Who Are Formula-fed Clinical Trial
Official title:
Infant Formula GI Tolerance Evaluation
| Verified date | May 2018 |
| Source | Nestlé |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Prospective, double-blind, randomized study of 2 infant formulas.
| Status | Completed |
| Enrollment | 79 |
| Est. completion date | January 19, 2018 |
| Est. primary completion date | January 19, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A to 19 Days |
| Eligibility |
Inclusion Criteria: - Healthy newborn singleton infant - Full-term (> 37 weeks gestation) - Birth weight = 2500 grams and = 4500 grams - 9-19 days of age on enrollment - Infant's mother has elected not to breastfeed prior to enrollment and infant has exclusively formula-fed for at least 3days prior to enrollment - Having obtained his/her legal representative's informed consent Exclusion Criteria: - Known or suspected cow-milk allergy - Currently receiving a specialty infant formula (e.g. extensively hydrolyzed, amino acid-based, metabolic), or soy-based or lactose free infant formula - Currently not tolerating (as perceived by the caregiver) their formula - Currently being treated for reflux - Currently experiencing gastrointestinal or respiratory symptoms secondary to an on-going infection or virus (e.g. gastrointestinal infection, upper respiratory infection, flu) - Congenital illness or malformation that may affect infant feeding and/or growth - Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment - Receiving prescription medication (with exception of treatment for thrush or topical medications) or home remedies, herbal preparations, or rehydration fluids that might affect GI tolerance (vitamin and mineral supplements excepted). - Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen). - Participation in another study that has not been approved as a concomitant study by Nestlé Nutrition. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Coastal Pediatric Associates | Charleston | South Carolina |
| United States | Ohio Pediatric Research Association | Dayton | Ohio |
| United States | Tanner Clinic | Layton | Utah |
| United States | Bluegrass Clinical Research, Inc. | Louisville | Kentucky |
| United States | Midsouth Center for Clinical Research, LLC | Memphis | Tennessee |
| United States | PediaResearch | Owensboro | Kentucky |
| United States | Avanza Medical Research Center | Pensacola | Florida |
| United States | Southwest Children's Research Associates | San Antonio | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Nestlé |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Infant GI Symptom Burden | Study personnel will administer questionnaire | 6 weeks | |
| Secondary | Stool pattern | Caregivers will document on diary records | 6 weeks | |
| Secondary | Spit-up and/or vomiting pattern | Caregivers will document on diary records | 6 weeks | |
| Secondary | Crying and fussing duration | Caregivers will document on diary records | 6 weeks | |
| Secondary | Formula intake | Caregivers will document on diary records | 6 weeks | |
| Secondary | Formula satisfaction questionnaire | Study personnel will administer questionnaire | 6 weeks | |
| Secondary | Weight (measured in grams) | Study personnel will measure | Enrollment and 6 weeks | |
| Secondary | Length (measured in centimeters) | Study personnel will measure | Enrollment and 6 weeks | |
| Secondary | Adverse events | Assessed throughout study | 2 weeks and 6 weeks |