Gastrointestinal Tolerability of a Partially Hydrolyzed Ready-to-feed Infant Formula in Healthy Newborns
NCT ID: NCT05097924
Last Updated: 2022-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2022-02-01
2022-03-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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NAN Supreme HypoAllergenic Starter Infant Formula in ready-to-feed format
Post-market observational study with formula feeding administered via standard of care
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
0 Months
24 Months
ALL
No
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Locations
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Dr Sulaiman Al Habib Hospital
Riyadh, , Saudi Arabia
Countries
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Other Identifiers
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21.07.INF
Identifier Type: -
Identifier Source: org_study_id
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