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

Growth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03276663
• Other study ID #: 15.01.INF
• Status: Completed
• Phase: N/A
• Start date: September 18, 2017
• Est. completion date: June 3, 2020

Study information

• Verified date: July 2020
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: June 3, 2020
• Est. primary completion date: December 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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.

Related Conditions & MeSH terms

• Growth

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens Picardie Site SUD	Amiens
France	CHU Bordeaux - Hôpital Pellegrin Enfants	Bordeaux
France	CHU de Caen	Caen
France	CHU Nantes - Hôpital Mère-Enfant	Nantes
France	Hopital Necker	Paris
France	Biofortis CIC	Saint-Herblain

Sponsors (2)

Lead Sponsor	Collaborator
Nestlé	Biofortis Mérieux NutriSciences

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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