Gastrointestinal Tolerability of a Partially Hydrolyzed Ready-to-feed Infant Formula in Healthy Newborns

Study Overview
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Brief Summary
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Gastrointestinal tolerability of a partially hydrolyzed, whey-based, ready-to-feed infant formula in healthy newborns during the birth hospitalization period: a post-market study

Official Title
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Gastrointestinal Tolerability of a Partially Hydrolyzed, Whey-based, Ready-to-feed Infant Formula in Healthy Newborns During the Birth Hospitalization Period: a Post-market Study

Conditions
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Infant Nutritional Physiological Phenomena, Infant Formula

Intervention / Treatment
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* Other: NAN Supreme HypoAllergenic Starter Infant Formula in ready-to-feed format


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent has been obtained from both parents or a legally acceptable representative (LAR). Full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2500 g and ≤ 4500 g. Parent(s) must have independently elected, before enrollment, to formula feed. Infant age ≤ 24 hours after birth. Child's parents / LAR are of legal age of consent, must understand the informed consent form and other study documents, and are willing and able to fulfill the requirements of the study protocol. Exclusion Criteria: Infant is exclusively breastfed. Evidence of significant cardiac, respiratory, endocrine, hematologic, gastrointestinal, or other systemic diseases, infections, or disorders. Infant has other condition that, in the judgement of the investigator, would make the infant inappropriate for entry into the study. Conditions that require infant feedings other than those specified in the protocol. Infant is currently participating in another interventional clinical trial that impacts study outcomes.

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: NAN Supreme HypoAllergenic Starter Infant Formula in ready-to-feed format|Post-market observational study with formula feeding administered via standard of care|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent-reported individual gastrointestinal (GI) symptoms and GI-related behaviors | The Newborn Infant GI Tolerance eDiary will be completed daily (preferably in the evening) by parents, who will document the frequency and severity of diarrhea, gassiness, spitting-up, vomiting, reflux, abdominal pain, fussiness, crying, and sleep patterns using a 6-point scale (from Never to Always). Higher scores indicate more symptoms of GI discomfort. | Daily through study completion (age 2 to 5 days) | 
| Parent-reported individual GI- and feeding-related behaviors | At discharge, parents will complete the Gastrointestinal Tract Function sub-scale of the NeoEAT questionnaire (either the Bottle-Feeding or the Mixed-Feeding version, depending on the mother's chosen feeding mode) to document GI- and feeding-related behaviors using a 6-point scale (from Never to Always). Higher scores indicate more symptoms of GI discomfort and problematic feeding behavior. | At study completion (age 2 to 5 days) | 
| Number of infants with specific GI characteristics | GI symptoms and GI-related behaviors, as documented by health care providers in the infants' hospital medical charts (e.g., diarrhea, constipation, and vomiting) | Daily through study completion (age 2 to 5 days) | 
| Number of feeds per day | Number of formula feeds per day, number of breastfeeds per day (if mixed fed), as documented by health care providers in the infants' hospital medical charts | Daily through study completion (age 2 to 5 days) |