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

Completed

• Conditions: Infant Formula; Infant Nutritional Physiological Phenomena

• Registration Number: NCT05097924
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-27
• Study First Posted: 2021-10-28
• Study Start: 2022-02-01
• Primary Completion: 2022-03-09
• Study Completion: 2022-03-09
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-04
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Parent-reported individual GI- and feeding-related behaviors	At study completion (age 2 to 5 days)	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.
Number of infants with specific GI characteristics	Daily through study completion (age 2 to 5 days)	GI symptoms and GI-related behaviors, as documented by health care providers in the infants' hospital medical charts (e.g., diarrhea, constipation, and vomiting)
Number of feeds per day	Daily through study completion (age 2 to 5 days)	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
Parent-reported individual gastrointestinal (GI) symptoms and GI-related behaviors	Daily through study completion (age 2 to 5 days)	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.

Trial Locations

Locations (1)

Dr Sulaiman Al Habib Hospital; 🇸🇦 Riyadh, Saudi Arabia