Probiotics to Prevent NEC Stage II+ in Very Preterm Infants - a Historical Control Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Necrotizing Enterocolitis
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 714
- Locations
- 1
- Primary Endpoint
- NEC
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Gorm Greisen
professor, consultant neonatologist
Rigshospitalet, Denmark
Eligibility Criteria
Inclusion Criteria
- •Gestational age less than 30 weeks
- •Admission during the first 3 days of life
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
NEC
Time Frame: 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 Outcomes
- Death with NEC(Birth to discharge home)
- Death(Birth to discharge home)