Probiotics to Prevent NEC - a Historical Control Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01670916

Enrollment

714

Registered

2012-08-22

Start date

2010-03-31

Completion date

2013-06-30

Last updated

2013-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotizing Enterocolitis

Keywords

Necrotizing enterocolitis, Probiotics, Preterm, Infant

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.

Interventions

DIETARY_SUPPLEMENTprobiotics

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.

Study design

Observational model

CASE_CONTROL

Eligibility

Sex/Gender

ALL

Age

No minimum to 3 Days

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
NEC	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

Measure	Time frame	Description
Death with NEC	Birth to discharge home	Death with a review board classification of NEC-II/III
Death	Birth to discharge home	—

Other

Measure	Time frame	Description
Positive culture of probiotic bacteria	Birth to discharge from Rigshospitalet	Growth of lactobacilli or bifidobacteria from a normally sterile fluid

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026