Clinical trial NCT03276663: Growth of Healthy Term Infants Fed a Partially Hydrolyzed Follow-up Formula
Official title: Effect of a New Formula With a Reduced Concentration of Partially Hydrolyzed Protein on Growth of Healthy Term Infants: an Open-label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: Biofortis Mérieux NutriSciences
First posted: 2017-09-08
Enrollment: 194
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, two-arm
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Growth velocity (weight gain in g/day) of healthy term formula-fed infants during the first 6 months
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie Site SUD
city: Bordeaux
country: France
facility: CHU Bordeaux - Hôpital Pellegrin Enfants
city: Caen
country: France
facility: CHU de Caen
city: Nantes
country: France
facility: CHU Nantes - Hôpital Mère-Enfant
city: Paris
country: France
facility: Hopital Necker
city: Saint-Herblain
country: France
facility: Biofortis CIC
Study officials:
affiliation: University Hospital, Bordeaux
name: Claude Billeaud
role: PRINCIPAL_INVESTIGATOR
References:
citation: Billeaud C, Adamon L, Piloquet H, Hays NP, Dupuis L, Metreau I, Leke A. A new partially hydrolyzed whey-based follow-on formula with age-adapted protein content supports healthy growth during the first year of life. Front Pediatr. 2022 Sep 28;10:937882. doi: 10.3389/fped.2022.937882. eCollection 2022.