Infloran® for Prevention of Necrotizing Enterocolitis

Oral Probiotics (Infloran®) for Prevention of Necrotizing Enterocolitis in Very Low Birth Weight Infants

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01751477

Enrollment

463

Registered

2012-12-18

Start date

2010-09-30

Completion date

2012-10-31

Last updated

2015-04-22

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

Conditions

Necrotizing Enterocolitis

Keywords

Very Low Birth Weight Infants, Probiotics, Necrotizing Enterocolitis

Brief summary

Necrotizing enterocolitis (NEC) is one of the most devastating gastrointestinal emergencies in preterm neonates and a leading cause of death and morbidity. The pathogenesis of NEC remains largely unclear, but it is widely considered as a multifactorial disease. Prematurity, enteral feeding, bacterial colonisation of the gut and intestinal ischemia have been proposed as major risk factors. Probiotics may prevent NEC by improving the maturity and function of the gut mucosal barrier, modulating the immune system, promoting colonization of the gut with beneficial organisms and preventing colonization by pathogens. A variety of clinical trials have evaluated the effect of different probiotic preparations on the occurrence of NEC in preterm infants. The results of recent metaanalyses suggest a benefit of probiotic bacteria in reducing the incidence of NEC and propose a change of practice. The aim of the study is to evaluate the efficacy of the probiotic preparation Infloran® in reducing the incidence of NEC after implementation in clinical routine in preterm (\< 34 weeks gestational age) very low birth weight infants compared to a historical cohort.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 7 Days

Healthy volunteers

Inclusion criteria

* Neonates admitted to the neonatal intensive care unit on day 1 of life * Very low birth weight (\<1500 gram) * Prematurity \< 34/0 weeks gestational age * For group receiving probiotics: 230 infants born after the 20/Sep/2010 (i.e. date of introduction of Infloran in clinical routine) * For control group (historical): 230 infants born before 2010

Exclusion criteria

* Malformation of the gut (omphalocele, gastroschisis, intestinal atresia) * Death before seven days of life, except due to NEC * Transfer to another hospital before 37 weeks of corrected gestational age, except those who were transferred to a partner clinic using the same protocol for probiotic supplementation * For group receiving probiotics: Infants who did not receive Infloran® starting in the first week of life or stopped before 34 weeks gestational age, except infants who developed NEC (reason for discontinuation of Infloran)

Design outcomes

Primary

Measure	Time frame	Description
Incidence of NEC	From birth to 37 weeks of gestational age (usually around 12 weeks)	NEC stages 2 or 3 according to Bell´s modified staging of NEC

Secondary

Measure	Time frame
Severity of NEC	From birth to 37 weeks of gestational age (usually around 12 weeks)
Influence of enteral feeding with human milk or formula on the incidence of NEC after the implementation of Infloran®	From birth to 37 weeks of gestational age (usually around 12 weeks)

Countries

Austria

Outcome results