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

Société des Produits Nestlé (SPN)150 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Infant Nutritional Physiological Phenomena Infant Formula

Interventions

NAN Supreme HypoAllergenic Starter Infant Formula in ready-to-feed formatOTHER

Post-market observational study with formula feeding administered via standard of care

Eligibility

Sex: ALLMin age: 0 MonthsMax age: 24 Months

Medical Language ↔ Plain English

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.

Locations (1)

Dr Sulaiman Al Habib Hospital

Riyadh, Saudi Arabia

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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)

Time frame: 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

Time frame: Daily through study completion (age 2 to 5 days)

Data from ClinicalTrials.gov

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