Growth of Healthy Term Infants Fed a Partially Hydrolyzed Follow-up Formula

Study Overview
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Brief Summary
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Growth of healthy term formula-fed infants who receive a single feeding regimen consisting of an existing partially hydrolyzed starter formula, then subsequently fed a partially hydrolyzed follow-up formula over the first year of life.

Official Title
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Effect of a New Formula With a Reduced Concentration of Partially Hydrolyzed Protein on Growth of Healthy Term Infants: an Open-label Study

Conditions
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Growth

Intervention / Treatment
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* Other: Formula feeding regimen


Participation Criteria
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Eligibility Criteria
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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 ≤ 14 days after birth (date of birth = Day 0). Full-term gestational birth (≥ 37 and ≤ 42 weeks). Weight at birth ≥ 2500 g and ≤ 4200 g Born to mothers with (normal) pre-pregnancy BMI ≥ 18.5 to < 26 kg/m2. For formula-fed infants: born to mothers who independently elected, before study enrollment, not to breastfeed, but having received any HM is permitted (not applicable for infants in the HM-fed group) For HM-fed infants: mothers intend to provide breast milk until age 6 months Infant's parent(s)/LAR is of legal age of consent, has sufficient command of the 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). 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). 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.

Ages Eligible for Study
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Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open-label, two-arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Formula fed group<br>Formula feeding regimen | Other: Formula feeding regimen<br>* The feeding regimen consists of an existing commercial starter formula followed by a new follow-up formula<br>|
| No Intervention: Human milk-fed group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth velocity (weight gain in g/day) of healthy term formula-fed infants during the first 6 months | compared to the WHO reference standards or to the human milk (HM)-fed comparator group. | 6 month |