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Probiotics to Prevent NEC - a Historical Control Study

NCT01670916 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 714

Last updated 2013-10-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Eligibility

Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-04-30
Completion
2013-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01670916 on ClinicalTrials.gov