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NCT02997826: BABYMILK

Effect of Infant Formula Intake on Infant Growth From 0 to 6 Months.

Completed NA Last updated 8 December 2022
What this trial tests

NA trial testing Infantil formula in Child Development in 100 participants. Completed in 30 October 2018.

Timeline
14 November 2016
Primary endpoint
30 October 2018
30 October 2018

Quick facts

Lead sponsorInstitut Pasteur de Lille
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment100
Start date14 November 2016
Primary completion30 October 2018
Estimated completion30 October 2018
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Institut Pasteur de Lille

Who can join

Adults 1 Day to 21 Days, any sex, with Child Development. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

From birth to 5 months, milk is the essential and unique food of the newborn. The French National Nutrition Program (PNNS) recommends exclusive breastfeeding "up to 6 months and at least 4 months for a healthy benefit". However, only 36% of infants 0-6 months of age are exclusively breastfed worldwide. Some mothers choose to give infant formula to their baby in the first few months of life. This decision may be a personal choice or be imposed by pathophysiological situations. The nutritional requirements of the infant are specific, which implies adequate nutrition. Infant formulas and follow-up formulas are therefore complex products, specially developed for a group of vulnerable consumers. In fact, the compositional and information requirements for infant formula are highly regulated. Even clinical studies are not required to market an infant formula, it is important to obtain objective date on infant growth. Therefore, this study proposes to evaluate the effect of the consumption of an infant formula on the growth of infants from 0 to 6 months in comparison with the growth curves of the World Health Organization (WHO).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Child Development

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02997826.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing