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

Primary Purpose

Necrotizing Enterocolitis, Sepsis

Status

Terminated

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Probiotics

About this trial

This is an interventional prevention trial for Necrotizing Enterocolitis focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Mothers of preterm infants
Pumping breast milk

Exclusion Criteria:

Neonatal congenital anomalies

Sites / Locations

Tel Aviv Medical Center

Outcomes

Primary Outcome Measures

all cause mortality at three months of age

incidence and severity of necrotizing enterocolitis by Bell's staging at Three months

occurrence of bacterial or fungal infection per blood,csf or urine cultures at three months

Secondary Outcome Measures

incidence of BPD, PVL, ROP

maternal adverse effects during treatment

Full Information

NCT ID

NCT00835874

First Posted

July 5, 2007

Last Updated

August 1, 2012

Sponsor

Tel-Aviv Sourasky Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00835874

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Terminated

Why Stopped

Difficulty in recruitment. Mothers of infants preferred to take probiotics bought over-the-counter over the possibility of being in a placebo group

Study Start Date

June 2007 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Necrotizing Enterocolitis, Sepsis

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Probiotics

Intervention Description

Lactobacillus acidophilus, b.lactis capsule. Once daily.2X 10 by the power of 10 bacteria per dose.

Primary Outcome Measure Information:

Title

all cause mortality at three months of age

Time Frame

3 months

Title

incidence and severity of necrotizing enterocolitis by Bell's staging at Three months

Time Frame

3 months

Title

occurrence of bacterial or fungal infection per blood,csf or urine cultures at three months

Time Frame

3 months

Secondary Outcome Measure Information:

Title

incidence of BPD, PVL, ROP

Time Frame

36 weeks

Title

maternal adverse effects during treatment

Time Frame

3 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Mothers of preterm infants Pumping breast milk Exclusion Criteria: Neonatal congenital anomalies

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shaul Dollberg

Organizational Affiliation

Tel Aviv Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Shira Benor

Organizational Affiliation

Tel Aviv Medical Center

Official's Role

Study Director

Facility Information:

Facility Name

Tel Aviv Medical Center

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

23934538

Citation

Benor S, Marom R, Ben Tov A, Armoni Domany K, Zaidenberg-Israeli G, Dollberg S. Probiotic supplementation in mothers of very low birth weight infants. Am J Perinatol. 2014 Jun;31(6):497-504. doi: 10.1055/s-0033-1353490. Epub 2013 Aug 9. Erratum In: Am J Perinatol. 2014 Jun;31(6):e1. Tov, Amir Ben [corrected to Ben Tov, Amir]; Domany, Keren Armoni [corrected to Armoni Domany, Keren]; Dosage error in published abstract; MEDLINE/PubMed abstract corrected.

Results Reference

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

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