Effects of Specific Lipid Fractions-enriched Infant Formulae

Infant Growth Clinical Trial

Official title:

Multicenter, Randomized, Double-blind, Parallel-group, Reference-controlled, Safety Pilot Study to Evaluate the Effects of Specific Lipid Fractions-enriched Infant Formulae in Infants Aged 0-4 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02111837
• Other study ID #: 07.16.INF.B
• Status: Completed
• Phase: N/A
• First received: April 9, 2014
• Last updated: April 9, 2014
• Start date: November 2009
• Est. completion date: December 2010

Study information

• Verified date: April 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of PersonnesItaly: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, randomized, double-blind, parallel-group, reference-controlled 4-month pilot safety study to evaluate the effects of specific lipid fractions-enriched infant formulae on growth of infants aged 0-4 months. The study will test the hypothesis that growth of infants fed the specific lipid fractions-enriched infant formulae will be noninferior to growth of infants fed standard infant formula.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 14 Days

Eligibility

Inclusion Criteria:

• Healthy newborn infant

• Infant is =14 days old on day of enrollment

• Gestational age =37 weeks (full term infants)

• Birth weight =2500 g and =4500 g

• Singleton birth

• Having obtained his/her parents'/legal representative's informed consent

Exclusion Criteria:

• Having any significant pre-natal and/or post-natal disease and/or congenital illness or malformation that may affect normal growth.

• Infant undergoing antibiotic therapy.

• Re-hospitalization for more than 2 days in the first 14 days of life.

• Parents not expected to comply with the protocol during the period of study participation.

• Infants currently participating in another trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Infant Growth

Intervention

Other:
• Standard infant formula

• Standard infant formula with PL1

• Standard infant formula with PL2

Locations

Country	Name	City	State
France	Groupe Hospitalier Pellegrin	Bordeaux
France	CHU de Caen	Caen	Cedex 9
France	Hôpital Bretonneau - UPM	Tours	Cedex 9
Italy	Istituto di Ostetricia e Ginecologia Neonatalogia	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Countries where clinical trial is conducted

France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean weight gain (g/day)		Enrollment to age 4 months	Yes