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

Necrotizing Enterocolitis Clinical Trial

Official title:

Prevention of NEC in Preterm Infants With B. Lactis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00977912
• Other study ID #: 08.09.INF
• Status: Terminated
• Phase: N/A
• First received: September 15, 2009
• Last updated: November 22, 2013
• Start date: November 2009
• Est. completion date: September 2013

Study information

• Verified date: November 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 318
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 48 Hours

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Intervention

Dietary Supplement:
• Probiotic supplementation
one capsule containing probiotics per day added to milk
• Milk containing placebo
one capsule containing placebo per day added to milk

Locations

Country	Name	City	State
South Africa	University of Witwatersrand & Chris Hani Baragwanath Hospital	Bertsham
South Africa	University of Witwatersrand & Rahima Moosa Mother & Child Hospital	Johannesburg
South Africa	University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital	Johannesburg

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NEC onset		6 weeks	No
Secondary	Antibiotic administration and stool microbiology		6 weeks	No