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

• Sponsor: Tel-Aviv Sourasky Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00835874
• Collaborator: (none)
• Enrollment: 57
• Location: 1
• Duration (Months): 25
• Patients Per Site Per Month: 2.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Necrotizing Enterocolitis; Sepsis	Drug: Probiotics	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Probiotic Administartion to Mothers of Preterm Infants to Prevent Necrotizing Enterocolitis and Sepsis
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Outcome Measures

Primary Outcome Measures

1. all cause mortality at three months of age [3 months]

2. incidence and severity of necrotizing enterocolitis by Bell's staging at Three months [3 months]

3. occurrence of bacterial or fungal infection per blood,csf or urine cultures at three months [3 months]

Secondary Outcome Measures

1. incidence of BPD, PVL, ROP [36 weeks]

2. maternal adverse effects during treatment [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Mothers of preterm infants

• Pumping breast milk

Exclusion Criteria:

• Neonatal congenital anomalies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tel-Aviv Sourasky Medical Center
• ClinicalTrials.gov Identifier: NCT00835874
• Other Study ID Numbers: TASMC-06-SD-363-CTIL
• First Posted: Feb 4, 2009
• Last Update Posted: Aug 2, 2012
• Last Verified: Aug 1, 2012

• 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: Sepsis; Toxemia; Enterocolitis; Enterocolitis, Necrotizing

Study Results

No Results Posted as of Aug 2, 2012