Probiotics to Prevent NEC - a Historical Control Study

Necrotizing Enterocolitis Clinical Trial

Official title:

Probiotics to Prevent NEC Stage II+ in Very Preterm Infants - a Historical Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670916
• Other study ID #: RHNEO-NEC01
• Status: Completed
• Phase: Phase 4
• First received: August 17, 2012
• Last updated: September 30, 2013
• Start date: March 2010
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 714
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

Inclusion Criteria:

• Gestational age less than 30 weeks

• Admission during the first 3 days of life

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Denmark	Department of Neonatology, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Positive culture of probiotic bacteria	Growth of lactobacilli or bifidobacteria from a normally sterile fluid	Birth to discharge from Rigshospitalet	Yes
Primary	NEC	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.	From birth until discharge home	No
Secondary	Death with NEC	Death with a review board classification of NEC-II/III	Birth to discharge home	No
Secondary	Death		Birth to discharge home	Yes