Impact of Infant Formula on Caregiver-perceived Intolerance
Not Applicable
Completed
- Conditions
- Healthy Infants
- Interventions
- Other: Routine infant formula
- Registration Number
- NCT03679234
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- Brief Summary
Understand the impact of switching to a commercially available infant formula on gastrointestinal symptoms
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
Inclusion Criteria
- Healthy infant
- Full-term (> 37 weeks gestation)
- Birth weight > 2500 and < 4500 g
- 14-60 days of age on enrollment
- Singleton birth
- Infant's mother has elected not to breastfeed prior to enrollment
- Infant exclusively formula-fed for at least 5 days prior to enrollment
- Caregiver perceives infant as very or extremely fussy according to perceived fussiness based on the previous 3 days
- Caregiver wishes to switch infant's formula
- Has not received solid foods
- 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. thickened, extensively hydrolyzed, amino acid-based, metabolic)
- Has switched formula more than two times since hospital discharge
- Currently experiencing gastrointestinal or respiratory symptoms secondary to an ongoing 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 probiotic supplements
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Routine infant formula Routine infant formula
- Primary Outcome Measures
Name Time Method Infant GI Symptom Burden 3 weeks Study personnel will administer questionnaire
- Secondary Outcome Measures
Name Time Method Formula Intake 24 hours Caregivers will document on diary records
Fussiness 24 hours Caregivers will document on diary records
Formula Satisfaction Questionnaire 3 weeks Study personnel will administer questionnaire
Adverse Events 24 hours and 3 weeks Assessed throughout study
Trial Locations
- Locations (7)
Norwich Pediatrics Group
🇺🇸Norwich, Connecticut, United States
Coastal Pediatric Associates
🇺🇸Charleston, South Carolina, United States
Midsouth Center for Clinical Research, LLC
🇺🇸Memphis, Tennessee, United States
Qualmedica Research
🇺🇸Owensboro, Kentucky, United States
Ohio Pediatric Research Association
🇺🇸Dayton, Ohio, United States
ClinPoint Trials
🇺🇸Waxahachie, Texas, United States
Tanner Clinic
🇺🇸Layton, Utah, United States