Necrotizing Enterocolitis, Sepsis
Conditions
Keywords
probiotic, preterm, lactation, breast feeding, necrotizing enterocolitis, sepsis, bacterial cultures, lactating mother, breast feeding of at least 50% of enteric feeding volume, Infant, very low birth weight
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
Interventions
DRUGProbiotics
Lactobacillus acidophilus, b.lactis capsule. Once daily.2X 10 by the power of 10 bacteria per dose.
Sponsors
Tel-Aviv Sourasky Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Mothers of preterm infants * Pumping breast milk
Exclusion criteria
* Neonatal congenital anomalies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| incidence of BPD, PVL, ROP | 36 weeks |
| maternal adverse effects during treatment | 3 months |
Countries
Israel
Outcome results
None listed