NCT01670916

Probiotics to Prevent NEC - a Historical Control Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 714 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 3 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Necrotizing Enterocolitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-03-01
• Primary completion: 2013-04-01
• Completion: 2013-06-01
• First posted: 2012-08-22
• Last updated: 2013-10-07

Locations

1 site across 1 country: Denmark