Probiotics to Prevent NEC - a Historical Control Study

NCT01670916 | Completed

• 1 other identifier: RHNEO-NEC01
• Study Type: observational
• Target: 714
• Locations: 1 country
• Sites: 1

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.

Conditions

Necrotizing Enterocolitis

Keywords

Necrotizing enterocolitis; Probiotics; Preterm; Infant

Outcome Measures

Primary Outcomes (1)

• NEC

  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.

  From birth until discharge home

Secondary Outcomes (2)

• Death with NEC

  Birth to discharge home

• Death

  Birth to discharge home

Other Outcomes (1)

• Positive culture of probiotic bacteria

  Birth to discharge from Rigshospitalet

Study Arms (2)

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

Control

Probiotics never given

Interventions

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.

Also known as: Bifiform, Ferrosan A/S, Idoform, Ferronan A/S

Probiotics

Eligibility Criteria

• Age: Up to 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborn infants admitted for special or intensive care

You may qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Neonatology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Lambaek 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):A5203.

  PMID: 26931192 DERIVED

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Premature Birth

Interventions

Probiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor, consultant neonatologist

Study Record Dates

• First Submitted: August 17, 2012
• First Posted: August 22, 2012
• Study Start: March 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 7, 2013

Record last verified: 2013-09

Locations

DK (1)