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

NCT05097924 | Completed

• 1 other identifier: 21.07.INF
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Infant Nutritional Physiological Phenomena; Infant Formula

Outcome Measures

Primary Outcomes (4)

• 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)

Interventions

NAN Supreme HypoAllergenic Starter Infant Formula in ready-to-feed format OTHER

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

Eligibility Criteria

• Age: 0 Months - 24 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborn infants

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Dr Sulaiman Al Habib Hospital

Riyadh, Saudi Arabia

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 28, 2021
• Study Start: February 1, 2022
• Primary Completion: March 9, 2022
• Study Completion: March 9, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-07

Locations

SA (1)