Skip to main content
OpenTrials
Completed

NCT Number: NCT05097924

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infant Nutritional Physiological Phenomena Infant Formula

Age range

0 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr Sulaiman Al Habib Hospital

Riyadh, Saudi Arabia

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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

Primary outcomes

  1. Parent-reported individual gastrointestinal (GI) symptoms and GI-related behaviors

    Time frame: 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.

  2. Parent-reported individual GI- and feeding-related behaviors

    Time frame: 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.

  3. Number of infants with specific GI characteristics

    Time frame: 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)

  4. Number of feeds per day

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 28, 2021
Registry last updated
Jul 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.