Probiotic Administartion to Mothers of Preterm Infants to Prevent Necrotizing Enterocolitis and Sepsis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Necrotizing Enterocolitis
- Sponsor
- Tel-Aviv Sourasky Medical Center
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- all cause mortality at three months of age
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Mothers of preterm infants
- •Pumping breast milk
Exclusion Criteria
- •Neonatal congenital anomalies
Outcomes
Primary Outcomes
all cause mortality at three months of age
Time Frame: 3 months
incidence and severity of necrotizing enterocolitis by Bell's staging at Three months
Time Frame: 3 months
occurrence of bacterial or fungal infection per blood,csf or urine cultures at three months
Time Frame: 3 months
Secondary Outcomes
- maternal adverse effects during treatment(3 months)
- incidence of BPD, PVL, ROP(36 weeks)