Probiotics to Prevent NEC - a Historical Control Study

This study is currently recruiting participants.

Verified August 2012 by Rigshospitalet, Denmark

Sponsor:

Information provided by (Responsible Party):

Gorm Greisen, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT01670916

First received: August 17, 2012

Last updated: August 21, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	August 17, 2012
Last Updated Date	August 21, 2012
Start Date ^ICMJE	March 2010
Estimated Primary Completion Date	February 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 21, 2012)	NEC [ Time Frame: From birth until discharge home ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01670916 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 21, 2012)	Death with NEC [ Time Frame: Birth to discharge home ] [ Designated as safety issue: No ] Death with a review board classification of NEC-II/III Death [ Time Frame: Birth to discharge home ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE (submitted: August 21, 2012)	Positive culture of probiotic bacteria [ Time Frame: Birth to discharge from Rigshospitalet ] [ Designated as safety issue: Yes ] Growth of lactobacilli or bifidobacteria from a normally sterile fluid
Original Other Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Probiotics to Prevent NEC - a Historical Control Study
Official Title ^ICMJE	Probiotics to Prevent NEC Stage II+ in Very Preterm Infants - a Historical Control Study
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 Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Newborn infants admitted for special or intensive care
Condition ^ICMJE	Necrotizing Enterocolitis
Intervention ^ICMJE	Dietary Supplement: probiotics Capsule with 1 x 109 Lactobacillus rhamnosus GG and 1 x 108 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. Other Names: Bifiform, Ferrosan A/S Idoform, Ferronan A/S
Study Group/Cohort (s)	Probiotics Capsule with 1 x 109 Lactobacillus rhamnosus GG and 1 x 108 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. Intervention: Dietary Supplement: probiotics Control Probiotics never given
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	700
Estimated Completion Date	June 2013
Estimated Primary Completion Date	February 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Gestational age less than 30 weeks Admission during the first 3 days of life
Gender	Both
Ages	up to 3 Days
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT01670916
Other Study ID Numbers ^ICMJE	RHNEO-NEC01
Has Data Monitoring Committee	Not Provided
Responsible Party	Gorm Greisen, Rigshospitalet, Denmark
Study Sponsor ^ICMJE	Rigshospitalet, Denmark
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Rigshospitalet, Denmark
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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