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

Infant Formula Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05097924
• Other study ID #: 21.07.INF
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: March 9, 2022

Study information

• Verified date: July 2022
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 9, 2022
• Est. primary completion date: March 9, 2022
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Infant Formula
• Infant Nutritional Physiological Phenomena

Intervention

Other:
• NAN Supreme HypoAllergenic Starter Infant Formula in ready-to-feed format
Post-market observational study with formula feeding administered via standard of care

Locations

Country	Name	City	State
Saudi Arabia	Dr Sulaiman Al Habib Hospital	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)