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Probiotics to Prevent NEC - a Historical Control Study

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ClinicalTrials.gov Identifier: NCT01670916
Recruitment Status : Completed
First Posted : August 22, 2012
Last Update Posted : October 7, 2013
Sponsor:
Information provided by (Responsible Party):
Gorm Greisen, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment
Necrotizing Enterocolitis Dietary Supplement: probiotics

Study Type : Observational
Actual Enrollment : 714 participants
Observational Model: Case Control
Official Title: Probiotics to Prevent NEC Stage II+ in Very Preterm Infants - a Historical Control Study
Study Start Date : March 2010
Actual Primary Completion Date : April 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Death with NEC [ Time Frame: Birth to discharge home ]
    Death with a review board classification of NEC-II/III

  2. Death [ Time Frame: Birth to discharge home ]

Other Outcome Measures:
  1. Positive culture of probiotic bacteria [ Time Frame: Birth to discharge from Rigshospitalet ]
    Growth of lactobacilli or bifidobacteria from a normally sterile fluid



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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670916


Locations
Denmark
Department of Neonatology, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gorm Greisen, professor, consultant neonatologist, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01670916     History of Changes
Other Study ID Numbers: RHNEO-NEC01
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: October 7, 2013
Last Verified: September 2013

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

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