NCT03276663

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

September 18, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2020

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

2.3 years

First QC Date

September 7, 2017

Last Update Submit

July 2, 2020

Conditions

Growth

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Formula fed group

OTHER

Formula feeding regimen

Other: Formula feeding regimen

Human milk-fed group

NO INTERVENTION

Interventions

Formula feeding regimenOTHER

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

Formula fed group

Eligibility Criteria

AgeUp to 14 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHU Amiens Picardie Site SUD

Amiens, 80054, France

Location

CHU Bordeaux - Hôpital Pellegrin Enfants

Bordeaux, 33000, France

Location

CHU de Caen

Caen, 14033, France

Location

CHU Nantes - Hôpital Mère-Enfant

Nantes, 44093, France

Location

Hopital Necker

Paris, 75015, France

Location

Biofortis CIC

Saint-Herblain, 44800, France

Location

Related Publications (1)

  • 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.

    PMID: 36245743DERIVED

Study Officials

  • Claude Billeaud

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Open-label, two-arm
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 8, 2017

Study Start

September 18, 2017

Primary Completion

December 19, 2019

Study Completion

June 3, 2020

Last Updated

July 7, 2020

Record last verified: 2020-07

Locations

FR(6)