A New Adaptive Feeding Plan for Newborns

Nestlé

Status: Completed

Conditions: Infant Nutrition

Treatments: Other: BSF + Lactoferrin + Probiotics; Other: BSF; Other: BSF + Lactoferrin + Probiotics + OS

Study type: Interventional

Funder types: Industry

Identifiers

NCT00984230

07.22.INF

Details and patient eligibility

About

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.

Enrollment: 186 estimated patients

Sex: All

Ages: 1 to 3 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

186 participants in 4 patient groups

Breastfeeding (Reference)

No Intervention group

Basic starter formula: BSF

Active Comparator group

Treatment:

Other: BSF

BSF + Lactoferrin + Probiotics + OS

Experimental group

Treatment:

Other: BSF + Lactoferrin + Probiotics + OS

BSF + Lactoferrin + Probiotics

Experimental group

Treatment:

Other: BSF + Lactoferrin + Probiotics