Probiotics to Prevent NEC - a Historical Control Study

Completed

• Conditions: Necrotizing Enterocolitis
• Interventions: Dietary Supplement: probiotics

• Registration Number: NCT01670916
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2012-08-17
• Study First Submitted QC: 2012-08-21
• Study First Posted: 2012-08-22
• Primary Completion: 2013-04
• Study Completion: 2013-06
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-30
• Last Update Posted: 2013-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 714

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Probiotics	probiotics	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.

Primary Outcome Measures

Name	Time	Method
NEC	From birth until discharge home	The clinical records of infants who had a discharge diagnosis of necrotizing enterocolitis are selected. Records of infants who had a prescription of metronidazole for a non-preventive purpose is added. The clinical records are abstracted. The abstracts and X-rays are presented to a review board that are blinded to the period of birth. The board classifies the cases as NEC-I, NEC-II, NEC-III, focal intestinal perforation, and OTHER.; NEC-II/III is the primary outcome.

Secondary Outcome Measures

Name	Time	Method
Death with NEC	Birth to discharge home	Death with a review board classification of NEC-II/III
Death	Birth to discharge home

Trial Locations

Locations (1)

Department of Neonatology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark