NCT02997826

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 16, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

2 years

First QC Date

December 16, 2016

Last Update Submit

December 6, 2022

Conditions

Child Development

Outcome Measures

Primary Outcomes (1)

  • Weight evolution of infants fed with infant formula

    from 0 to 3 months

Secondary Outcomes (3)

  • Weight evolution of infants fed with infant formula

    from 0 to 6 months

  • Height evolution of infants fed with infant formula

    from 0 to 6 months

  • Head circumference evolution of infants fed with infant formula

    from 0 to 6 months

Study Arms (1)

1 to 21-days old child

OTHER
Other: Infantil formula

Interventions

Infantil formulaOTHER
1 to 21-days old child

Eligibility Criteria

Age1 Day - 21 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • to 3 weeks
  • Infants whose mothers do not wish or can not breastfeed for personal or medical reasons
  • Child followed by a general practitioner or pediatrician
  • Informed consent form signed by the legal representatives of the subject
  • Commitment of legal representatives to follow the constraints generated by the study
  • Insured

You may not qualify if:

  • Nursing mother
  • Infant born prematurely before 37 weeks of amenorrhea
  • Child allergic to cow's milk proteins
  • Pathological pregnancy (hypertension, infection, gestational diabetes, etc.);
  • Chronic or acute illness (metabolic or neuromuscular diseases, epilepsy, asthma, diabetes, digestive, renal, cardiac or haematological diseases);
  • Incapacity for the legal representative(s) to understand or adhere to the protocol
  • Mother smoking or vapoting during pregnancy;
  • Legal representatives deprived of liberty
  • Legal representatives in a position to judicial protection
  • Weight of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards
  • Subject height according to age and sex, not between the 3rd and the 97th percentile of the WHO Child Growth Standards
  • BMI of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards
  • Head circumference of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Pasteur de Lille

Lille, 59000, France

Location

Study Officials

  • Jean-Michel Lecerf, MD

    Institut Pasteur de Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 16, 2016

First Posted

December 20, 2016

Study Start

November 14, 2016

Primary Completion

October 30, 2018

Study Completion

October 30, 2018

Last Updated

December 8, 2022

Record last verified: 2022-12

Locations

FR(1)