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

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

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.

Study Overview

• Status: Completed
• Conditions: Growth
• Intervention / Treatment: Other: Formula feeding regimen

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens Picardie Site Sud
  • Bordeaux, France, 33000
    • CHU Bordeaux - Hôpital Pellegrin Enfants
  • Caen, France, 14033
    • CHU de Caen
  • Nantes, France, 44093
    • CHU Nantes - Hopital Mere-Enfant
  • Paris, France, 75015
    • Hopital Necker
  • Saint-Herblain, France, 44800
    • Biofortis CIC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nestlé
• Collaborators: Biofortis Mérieux NutriSciences
• Investigators: Principal Investigator: Claude Billeaud, CHU Bordeaux

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2017
• Primary Completion (Actual): December 19, 2019
• Study Completion (Actual): June 3, 2020

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (Actual): September 8, 2017

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 15.01.INF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No