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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
  Purpose

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.


Condition Intervention Phase
Necrotizing Enterocolitis
 Dietary Supplement: probiotics
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Probiotics to Prevent NEC Stage II+ in Very Preterm Infants - a Historical Control Study

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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


Estimated Enrollment: 700
Study Start Date: March 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
 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
Control
Probiotics never given

  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Newborn infants admitted for special or intensive care

Criteria

Inclusion Criteria:

  • Gestational age less than 30 weeks
  • Admission during the first 3 days of life
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670916

Locations
Denmark
Department of Neonatology, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Gorm Greisen, MD, DrMedSci     +4535451326     ggreisen@rh.dk    
Principal Investigator: Irina L Jensen, MD            
Sponsors and Collaborators
Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Gorm Greisen, professor, consultant neonatologist, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01670916     History of Changes
Other Study ID Numbers: RHNEO-NEC01
Study First Received: August 17, 2012
Last Updated: August 21, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Necrotizing enterocolitis
Probiotics
Preterm
Infant

Additional relevant MeSH terms:
Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 19, 2013