Probiotic Administartion to Mothers of Preterm Infants to Prevent Necrotizing Enterocolitis and Sepsis

Not Applicable

Terminated

• Conditions: Necrotizing Enterocolitis; Sepsis

• Registration Number: NCT00835874
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

We hypothesize that supplementing maternal diet with probiotics will decrease the incidence of feeding intolerance, necrotizing enterocolitis and sepsis in preterm infants fed breastmilk.

Detailed Description

Oral probiotics have previously been shown to prevent necrotizing enterocolitis in preterm infants. A few reports of sepsis by a probiotic bacteria have impeded implementation of oral probiotic supplementation in most NICUs. Considering the proven immunomodulatory effect of maternal probiotics on breastfed infants of atopic mothers, we would like to explore the indirect effects of maternal probiotics on preterm infants

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-07-05
• Study First Submitted QC: 2009-02-03
• Study First Posted: 2009-02-04
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-01
• Last Update Posted: 2012-08-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Mothers of preterm infants
• Pumping breast milk

Exclusion Criteria

• Neonatal congenital anomalies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
all cause mortality at three months of age	3 months
incidence and severity of necrotizing enterocolitis by Bell's staging at Three months	3 months
occurrence of bacterial or fungal infection per blood,csf or urine cultures at three months	3 months

Secondary Outcome Measures

Name	Time	Method
incidence of BPD, PVL, ROP	36 weeks
maternal adverse effects during treatment	3 months

Trial Locations

Locations (1)

Tel Aviv Medical Center; 🇮🇱 Tel Aviv, Israel