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

Société des Produits Nestlé (SPN)318 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

318

Conditions

Necrotizing Enterocolitis

Interventions

Probiotic supplementationDIETARY_SUPPLEMENT

one capsule containing probiotics per day added to milk

Milk containing placeboDIETARY_SUPPLEMENT

one capsule containing placebo per day added to milk

Eligibility

Sex: ALLMin age: 12 HoursMax age: 48 HoursHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

University of Witwatersrand & Chris Hani Baragwanath Hospital

Bertsham, South Africa

University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital

Johannesburg, South Africa

University of Witwatersrand & Rahima Moosa Mother & Child Hospital

Johannesburg, South Africa

Outcomes

Primary Outcomes

NEC onset

Time frame: 6 weeks

Secondary Outcomes

Antibiotic administration and stool microbiology

Time frame: 6 weeks

Data from ClinicalTrials.gov

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