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

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

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 Overview

• Status: Completed
• Conditions: Infant Formula; Infant Nutritional Physiological Phenomena
• Intervention / Treatment: Other: NAN Supreme HypoAllergenic Starter Infant Formula in ready-to-feed format

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Dr Sulaiman Al Habib Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 2 years (CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Newborn infants

Description

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 Plan

How is the study designed?

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Nestlé

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2022
• Primary Completion (ACTUAL): March 9, 2022
• Study Completion (ACTUAL): March 9, 2022

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (ACTUAL): October 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 21.07.INF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No