Impact of Infant Formula on Caregiver-perceived Intolerance

Nestlé

Status

Completed

Conditions

Healthy Infants

Treatments

Other: Routine infant formula

Study type

Interventional

Funder types

Industry

Identifiers

18.01.US.INF

Details and patient eligibility

About

Understand the impact of switching to a commercially available infant formula on gastrointestinal symptoms

Enrollment

51 patients

Sex

All

Ages

14 to 60 days old

Volunteers

Accepts Healthy Volunteers

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.