Probiotics to Prevent NEC - a Historical Control Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gorm Greisen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01670916
First received: August 17, 2012
Last updated: September 30, 2013
Last verified: September 2013

August 17, 2012
September 30, 2013
March 2010
April 2013   (final data collection date for primary outcome measure)
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.

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 ] [ 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 ]
Same as current
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
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
Not Provided

*   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
Both
up to 3 Days
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01670916
RHNEO-NEC01
Not Provided
Gorm Greisen, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
Not Provided
Rigshospitalet, Denmark
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP