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Role of Probiotics for Prevention of NEC in Preterm VLBW Infants

NCT02650869 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-01-08

No results posted yet for this study

Summary

This prospective randomized double-blind control trial is carrying out in the neonatal unit of Sylhet MAG Osmani Medical College Hospital, Sylhet between July 2012 to December 2015 with the diagnosis of preterm (\<33 weeks gestation) VLBW (birth weight \<1500g) and fulfilling the inclusion criteria (able to tolerate oral feed and survive beyond 48h of life) were included in this study. Babies with suspicion of clinical sepsis, presence of perinatal asphyxia, major congenital anomaly and babies who expired due to other neonatal illness were excluded. Gestation was assessed from history of last menstrual period and after birth by new Ballard scores. A study protocol was approved by the Institutional Ethics Committee of Sylhet M.A.G Osmani Medical College, Sylhet.

Conditions

  • Necrotizing Enterocolitis

Interventions

DIETARY_SUPPLEMENT

Probiotics

probiotics at a dose of 3x109 CFU/day. (Cap TS6 probiotic + contain Bifidobacterium spp., Lactobacillus at 6x109 CFU = 6 billion CFU manufactured by TENSALL BIO-TECH CO.LTD.Taiwan, distributed by Century Health Care, Bangladesh)

DIETARY_SUPPLEMENT

Breast milk

Normal breast milk will be given as part of standard care

Sponsors & Collaborators

  • Sylhet M.A.G.Osmani Medical College

    lead OTHER

Principal Investigators

  • Prof. M. Monojjir Ali, FCPS · Professor and Head, Department of Paediatrics, Sylhet M.A.G.Osmani Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Week
Max Age
33 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-12-31
Completion
2015-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02650869 on ClinicalTrials.gov