Probiotics to Prevent NEC - a Historical Control Study

Rigshospitalet

Status: Completed

Conditions: Necrotizing Enterocolitis

Treatments: Dietary Supplement: probiotics

Study type: Observational

Funder types: Other

Identifiers

NCT01670916

RHNEO-NEC01

Details and patient eligibility

About

Probiotics is given routinely to infants admitted to the department of neonatology during the first 3 days of life with gestational age less than 30 weeks since March 2010. The incidence of necrotizing enterocolitis Bell stage II and III will be assessed blindly from clinical records. It is hypothesised that the incidence of NEC will decrease. Infants admitted from 1 March 2010 to 28 February 2013 will be compared to infants admitted 1 Dec 2007 to 30 Nov 2009 will be compared.

Enrollment: 714 patients

Sex: All

Ages: Under 3 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Gestational age less than 30 weeks
• Admission during the first 3 days of life

Trial design

714 participants in 2 patient groups

Probiotics

Description:

Capsule with 1 x 10\*\*9 Lactobacillus rhamnosus GG and 1 x 10\*\*8 Bifidobacterium BB12. Two capsules once a day. The capsules are opened and the content is dissolved in mother's milk or water if the baby is given any milk. In tube fed infants, two drops are given in the mouth and the rest in the nasogastric tube.

Treatment:

Dietary Supplement: probiotics

Control

Description:

Probiotics never given