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Probiotics to Prevent NEC - a Historical Control Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01670916
First Posted: August 22, 2012
Last Update Posted: October 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gorm Greisen, Rigshospitalet, Denmark
August 17, 2012
August 22, 2012
October 7, 2013
March 2010
April 2013   (Final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01670916 on ClinicalTrials.gov Archive Site
  • Death with NEC [ Time Frame: Birth to discharge home ]
    Death with a review board classification of NEC-II/III
  • Death [ Time Frame: Birth to discharge home ]
Same as current
Positive culture of probiotic bacteria [ Time Frame: Birth to discharge from Rigshospitalet ]
Growth of lactobacilli or bifidobacteria from a normally sterile fluid
Same as current
 
Probiotics to Prevent NEC - a Historical Control Study
Probiotics to Prevent NEC Stage II+ in Very Preterm Infants - a Historical Control Study
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.
Not Provided
Observational
Observational Model: Case Control
Not Provided
Not Provided
Non-Probability Sample
Newborn infants admitted for special or intensive care
Necrotizing Enterocolitis
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.
Other Names:
  • Bifiform, Ferrosan A/S
  • Idoform, Ferronan A/S
  • 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.
    Intervention: Dietary Supplement: probiotics
  • Control
    Probiotics never given
Lambæk ID, Fonnest G, Gormsen M, Brok J, Greisen G. Probiotics to prevent necrotising enterocolitis in very preterm infants. Dan Med J. 2016 Mar;63(3). pii: A5203.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
714
June 2013
April 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Gestational age less than 30 weeks
  • Admission during the first 3 days of life
Sexes Eligible for Study: All
up to 3 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01670916
RHNEO-NEC01
Not Provided
Not Provided
Not Provided
Gorm Greisen, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
Not Provided
Rigshospitalet, Denmark
September 2013