CompletedNot Applicable

Growth and Metabolic Biomarkers of Healthy Term Infants Fed Formulas With Staged Protein Concentrations Over the First Year of Life

France691 participantsStarted 2015-10

Plain-language summary

Growth and metabolic biomarkers of healthy term infants fed formulas with staged protein concentrations over the first year of life

Who can participate

Age range

0 Days – 7 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Having obtained his/her parents' (or his/her legally accepted representative's \[LAR's\]) written informed consent and having evidence of personally signed and dated informed consent document indicating that the infant's parents/LAR have been informed of all pertinent aspects of the study.
. Age ≤ 7 days after birth (date of birth = Day 0)
. Full-term gestational birth (≥ 37 and ≤ 42 weeks)
. Born to mothers with pre-pregnancy body mass index (BMI) ≥ 18.5 and \< 26 kg/m2
. Born to mothers who independently elected, before study enrollment, not to breastfeed (not applicable for infants in the HM-fed comparator group)
. Weight ≥ 2'500 g and ≤ 4'200 g
. Infant's parent(s)/LAR is of legal age of consent, has sufficient command of French language to complete the informed consent and other study documents, and is willing and able to fulfill the requirements of the study protocol
. Infant's parent(s)/LAR is able to be contacted directly by telephone throughout the study

Exclusion criteria

. Born to mothers with hormonal or metabolic disease (e.g. Type-1, Type-2, or gestational diabetes diagnosed according to standardized criteria)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Growth velocity of formula regimen 1 and 2 versus WHO growth curve

Timeframe: 0-6 months

Growth velocity (g/day) of formula regimen 1 and 2 versus a human milk (HM)-fed comparator group

Timeframe: 0-6 months

Trial details

NCT IDNCT02646969

SponsorSociété des Produits Nestlé (SPN)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-07

View on ClinicalTrials.gov More Healthy Term Infants trials