Necrotizing Enterocolitis (Nec) and B. Lactis in Premature Babies

Nestlé

Status: Terminated

Conditions: Necrotizing Enterocolitis

Treatments: Dietary Supplement: Milk containing placebo; Dietary Supplement: Probiotic supplementation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00977912

08.09.INF

Details and patient eligibility

About

The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.

Enrollment: 318 patients

Sex: All

Ages: 12 to 48 hours old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Weight between 800 - 1500g
• Tolerating enteral feeding within 48 hours
• Having obtained his/her parents or legal representative informed consent

Exclusion criteria

• Chromosomal abnormality
• Hydrops featalis
• Congenital malformation of the gastrointestinal tract
• Congenital heart defects or other major congenital abnormalities likely to affect feeding and/or feeding tolerance
• Currently participating in another clinical trial

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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318 participants in 2 patient groups, including a placebo group

"Milk" containing B. Lactis

Experimental group

Description:

"Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula.

Treatment:

Dietary Supplement: Probiotic supplementation

"Milk" containing placebo

Placebo Comparator group

Description:

"Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula.

Treatment:

Dietary Supplement: Milk containing placebo