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Completed

NCT Number: NCT01670916

Probiotics to Prevent NEC - 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.

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Key information

Conditions

Necrotizing Enterocolitis Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 3 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neonatology, Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age less than 30 weeks
  • Admission during the first 3 days of life

Treatment and study plan

Probiotics

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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 outcomes

  1. Positive culture of probiotic bacteria

    Time frame: Birth to discharge from Rigshospitalet

    Growth of lactobacilli or bifidobacteria from a normally sterile fluid

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Probiotics to Prevent NEC Stage II+ in Very Preterm Infants - a Historical Control Study

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 22, 2012
Registry last updated
Oct 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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