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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2009 by Tel-Aviv Sourasky Medical Center. Recruitment status was Active, not recruiting

First Received on July 5, 2007. Last Updated on March 4, 2010 History of Changes

Sponsor:	Tel-Aviv Sourasky Medical Center
Information provided by:	Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:	NCT00835874

Purpose

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

Condition	Intervention
Necrotizing Enterocolitis Sepsis	Drug: Probiotics

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Probiotic Administartion to Mothers of Preterm Infants to Prevent Necrotizing Enterocolitis and Sepsis

Resource links provided by NLM:

MedlinePlus related topics: Breast Feeding Premature Babies Sepsis

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:

all cause mortality at three months of age [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
incidence and severity of necrotizing enterocolitis by Bell's staging at Three months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
occurrence of bacterial or fungal infection per blood,csf or urine cultures at three months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

incidence of BPD, PVL, ROP [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
maternal adverse effects during treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	June 2007
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Mothers of preterm infants
Pumping breast milk

Exclusion Criteria:

Neonatal congenital anomalies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835874

Locations

Israel
Tel Aviv Medical Center
Tel Aviv, Israel, 64239

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

Principal Investigator:	Shaul Dollberg	Tel Aviv Medical Center
Study Director:	Shira Benor	Tel Aviv Medical Center

More Information

No publications provided

Responsible Party:	Shaul Dollberg, Tel Aviv Medical Center
ClinicalTrials.gov Identifier:	NCT00835874 History of Changes
Other Study ID Numbers:	TASMC-06-SD-363-CTIL
Study First Received:	July 5, 2007
Last Updated:	March 4, 2010
Health Authority:	Israel: Ethics Commission

Keywords provided by Tel-Aviv Sourasky Medical Center:

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

Additional relevant MeSH terms:

Enterocolitis
Sepsis
Toxemia
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases

Digestive System Diseases
Intestinal Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012