A New Adaptive Feeding Plan for Newborns

Infant Nutrition Clinical Trial

Official title:

A New Adaptive Feeding Plan for Newborns: Effects on Gut Maturity and Gut Microbiota

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984230
• Other study ID #: 07.22.INF
• Status: Completed
• Phase: N/A
• First received: September 10, 2009
• Last updated: June 4, 2013
• Start date: September 2009
• Est. completion date: February 2011

Study information

• Verified date: June 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité de Protection des Personnes
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical trial is to identify the infant formula(s) for which the investigators get the closest gut maturation index compared to the one they get with breastfed babies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

Inclusion Criteria:

• Healthy newborn infant

• Full term infant (= 37 weeks gestation; < 42 weeks gestation)

• Birth weight from 2500g to 4500g

• For the formula-fed groups: babies whose mothers elected not to breastfeed at all

• For the breastfed group: babies whose mothers elected to exclusively breastfeed for at least 2 months

• Newborn whose parents / caregivers can be expected to comply with the protocol

• Study explained and written information given

• Informed consent signed

Exclusion Criteria:

• Mother who had antibiotics in the 7 days preceding delivery

• Caesarian section

• Multiple birth

• Congenital illness or malformation that may affect normal growth

• Significant pre-natal and/or post-natal disease

• Newborn participating in another clinical trial

Study Design

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

Related Conditions & MeSH terms

• Infant Nutrition

Intervention

Other:
• BSF
feeding amount according to individual baby need
• BSF + Lactoferrin + Probiotics
feeding amount according to individual baby need
• BSF + Lactoferrin + Probiotics + OS
feeding amount according to individual baby need

Locations

Country	Name	City	State
Austria	Department of Pediatrics	Vienna
France	Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse	Lyon CEDEX 04
France	Maternité Régionale, Service de Néonatologie	Nancy
France	Service de Néonatologie	Nantes
France	Hôpital Charles Nicolle, Département de Pédiatrie	Rouen
Greece	Alexandra Regional General Hospital, Department of Neonatology	Palaio Faliro	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Countries where clinical trial is conducted

Austria,  France,  Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gut maturation : Specific proteins in stools		3rd day, at 1 week, 2 weeks and 1 month of age	No
Secondary	Growth and gut microbiota		At 1 month and 2 months	Yes