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

Age range0 Days – 7 Days

SexALL

See this in plain English?

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

✓. 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

✕. Born to mothers with hormonal or metabolic disease (e.g. Type-1, Type-2, or gestational diabetes diagnosed according to standardized criteria)
✕. Born to mothers who smoked \> 10 cigarettes per day during pregnancy
✕. Born to mothers who used illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (\> 3 alcoholic beverages per week) during pregnancy
✕. Cognitive or physical developmental disorders (e.g. malabsorptive disorders such as short bowel syndrome; neurological and congenital disorders that may delay growth such as cerebral palsy, agenesis of the corpus callosum, spina bifida, Down Syndrome, Cri Du Chat; disorders that may lead to obesity such as Prader willi syndrome, Angelman syndrome; other renal, hepatic, pancreatic, or cardiovascular disorders)
✕. Received radiation therapy (eg. scannography or interventional radiology)
✕. Participation in any other clinical trial prior to enrollment
✕. Infants or infant's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures

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

NCT IDNCT02646969

SponsorSociété des Produits Nestlé (SPN)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-07

Who can participate

Age range0 Days – 7 Days

SexALL

See this in plain English?

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

✓. 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

✕. Born to mothers with hormonal or metabolic disease (e.g. Type-1, Type-2, or gestational diabetes diagnosed according to standardized criteria)
✕. Born to mothers who smoked \> 10 cigarettes per day during pregnancy
✕. Born to mothers who used illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (\> 3 alcoholic beverages per week) during pregnancy
✕. Cognitive or physical developmental disorders (e.g. malabsorptive disorders such as short bowel syndrome; neurological and congenital disorders that may delay growth such as cerebral palsy, agenesis of the corpus callosum, spina bifida, Down Syndrome, Cri Du Chat; disorders that may lead to obesity such as Prader willi syndrome, Angelman syndrome; other renal, hepatic, pancreatic, or cardiovascular disorders)
✕. Received radiation therapy (eg. scannography or interventional radiology)
✕. Participation in any other clinical trial prior to enrollment
✕. Infants or infant's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures