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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-18

Study Completion Date

2020-06-03

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.

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Detailed Description

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Conditions

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Growth

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Open-label, two-arm

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Formula fed group

Formula feeding regimen

Group Type OTHER

Formula feeding regimen

Intervention Type OTHER

The feeding regimen consists of an existing commercial starter formula followed by a new follow-up formula

Human milk-fed group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Formula feeding regimen

The feeding regimen consists of an existing commercial starter formula followed by a new follow-up formula

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Age ≤ 14 days after birth (date of birth = Day 0).
3. Full-term gestational birth (≥ 37 and ≤ 42 weeks).
4. Weight at birth ≥ 2500 g and ≤ 4200 g
5. Born to mothers with (normal) pre-pregnancy BMI ≥ 18.5 to \< 26 kg/m2.
6. 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)
7. For HM-fed infants: mothers intend to provide breast milk until age 6 months
8. 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.
9. Infant's parent(s)/LAR is able to be contacted directly by telephone throughout the study.

Exclusion Criteria

1. Born to mothers with hormonal or metabolic disease (e.g. Type-1, Type-2, or gestational diabetes diagnosed according to standardized criteria).
2. Born to mothers who smoked \> 10 cigarettes per day during pregnancy.
3. Born to mothers who used illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (\> 3 alcoholic beverages per week) during pregnancy.
4. 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).
5. Participation in any other clinical trial prior to enrollment.
6. Infants or infant's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures.

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes