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NCT Number: NCT02997826

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

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).

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Key information

Conditions

Child Development

Age range

1 day–21 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Pasteur de Lille

Lille, 59000, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 0 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

Exclusion criteria

  • 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;
  • Subject involved in another clinical study or in an exclusion period from another study
  • 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

Treatment and study plan

Infantil formula

Other

Primary outcomes

  1. Weight evolution of infants fed with infant formula

    Time frame: from 0 to 3 months

Secondary outcomes

  1. Weight evolution of infants fed with infant formula

    Time frame: from 0 to 6 months

  2. Height evolution of infants fed with infant formula

    Time frame: from 0 to 6 months

  3. Head circumference evolution of infants fed with infant formula

    Time frame: from 0 to 6 months

Sponsors and collaborators

Lead sponsor

Institut Pasteur de Lille

Other

Registry information

Official study title

Effect of Infant Formula Consumption on Infant Growth From 0 to 6 Months

Acronym: BABYMILK

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 20, 2016
Registry last updated
Dec 8, 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.

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