search
Back to results

Role of Probiotics for Prevention of NEC in Preterm VLBW Infants (Probiotics)

Primary Purpose

Necrotizing Enterocolitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Probiotics
Breast milk
Sponsored by
Sylhet M.A.G.Osmani Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Necrotizing Enterocolitis focused on measuring Necrotizing Enterocolitis, probiotics, very low birth weight

Eligibility Criteria

1 Week - 33 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All newborn infant preterm (<33 weeks gestation to 28 weeks gestation) VLBW (birth weight <1500gm to 1000 gm)
  • Able to tolerate oral feed
  • Informed consent by the parents or guardian

Exclusion Criteria:

  • Evidence or suspicion of clinical sepsis before the baby is randomised
  • Presence of perinatal asphyxia
  • Presence of major congenital anomali
  • Death within first week of life due to other neonatal illness

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Standard care + Breast milk+ Probiotics

    Standard care

    Arm Description

    The study group will be fed with probiotics at a dose of 3x109 CFU/day. (Cap TS6 probiotic + contain Bifidobacterium spp., Lactobacillus at 6x109 CFU = 6 billion CFU) dissolved with 6 ml of milk then give 3 ml (3 billion probiotics) once daily with breast milk from first feeding.

    The control group will be given standard care without the addition of probiotics

    Outcomes

    Primary Outcome Measures

    Necrotizing Enterocolitis: Occurrence of NEC (stage II and III) by Modified Bell's classification
    The occurrence of NEC (stage II and III) by modified Bell's classification

    Secondary Outcome Measures

    Enteral feeding
    days to achieve full enteral feeding
    Hospital stay
    maximum days of hospital stay
    weight in Kg
    weight in kg

    Full Information

    First Posted
    December 31, 2015
    Last Updated
    January 7, 2016
    Sponsor
    Sylhet M.A.G.Osmani Medical College
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02650869
    Brief Title
    Role of Probiotics for Prevention of NEC in Preterm VLBW Infants
    Acronym
    Probiotics
    Official Title
    Role of Probiotics for Prevention of Necrotizing Enterocolitis in Preterm Very Low Birth Weight Infants: A Double Blind Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2012 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sylhet M.A.G.Osmani Medical College

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    Detailed Description
    Background: Necrotizing enterocolitis (NEC) is the most common acquired disease of the gastrointestinal tract in preterm very low birth weight infants and associated with increased morbidity and mortality. Prophylactic enteral probiotic supplementation may play a role in reducing NEC and potentially provide benefits to preterm very low birth weight neonates. The objective was to evaluate the efficacy of orally administered probiotics in preventing necrotizing enterocolitis (NEC) in preterm very low birth weight (VLBW) infants. This prospective, randomized double blind controlled trial is undergoing in 102 preterm (28-33 weeks gestation) VLBW (birth weight 1000-1499g) neonates fulfilling the inclusion criteria. The study group was fed with probiotics once daily with breast milk from first feeding and the control group only breast milk without the addition of probiotics. The primary outcome was the development of NEC (stage II and III). NEC is categorized by modified Bell's classification. Probiotic supplementation reduces the frequency of necrotising enterocolitis in preterm neonates with very low birth weight. It is also associated with faster achievement of full enteral feeding and shorter duration of hospital stay.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Necrotizing Enterocolitis
    Keywords
    Necrotizing Enterocolitis, probiotics, very low birth weight

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard care + Breast milk+ Probiotics
    Arm Type
    Experimental
    Arm Description
    The study group will be fed with probiotics at a dose of 3x109 CFU/day. (Cap TS6 probiotic + contain Bifidobacterium spp., Lactobacillus at 6x109 CFU = 6 billion CFU) dissolved with 6 ml of milk then give 3 ml (3 billion probiotics) once daily with breast milk from first feeding.
    Arm Title
    Standard care
    Arm Type
    Active Comparator
    Arm Description
    The control group will be given standard care without the addition of probiotics
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Probiotics
    Other Intervention Name(s)
    TS 6 Probiotics
    Intervention Description
    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)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Breast milk
    Intervention Description
    Normal breast milk will be given as part of standard care
    Primary Outcome Measure Information:
    Title
    Necrotizing Enterocolitis: Occurrence of NEC (stage II and III) by Modified Bell's classification
    Description
    The occurrence of NEC (stage II and III) by modified Bell's classification
    Time Frame
    10 days
    Secondary Outcome Measure Information:
    Title
    Enteral feeding
    Description
    days to achieve full enteral feeding
    Time Frame
    10 days
    Title
    Hospital stay
    Description
    maximum days of hospital stay
    Time Frame
    10 days
    Title
    weight in Kg
    Description
    weight in kg
    Time Frame
    10 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Week
    Maximum Age & Unit of Time
    33 Weeks
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All newborn infant preterm (<33 weeks gestation to 28 weeks gestation) VLBW (birth weight <1500gm to 1000 gm) Able to tolerate oral feed Informed consent by the parents or guardian Exclusion Criteria: Evidence or suspicion of clinical sepsis before the baby is randomised Presence of perinatal asphyxia Presence of major congenital anomali Death within first week of life due to other neonatal illness
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Prof. M. Monojjir Ali, FCPS
    Organizational Affiliation
    Professor and Head, Department of Paediatrics, Sylhet M.A.G.Osmani Medical College
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17336180
    Citation
    Sharma R, Tepas JJ 3rd, Hudak ML, Mollitt DL, Wludyka PS, Teng RJ, Premachandra BR. Neonatal gut barrier and multiple organ failure: role of endotoxin and proinflammatory cytokines in sepsis and necrotizing enterocolitis. J Pediatr Surg. 2007 Mar;42(3):454-61. doi: 10.1016/j.jpedsurg.2006.10.038.
    Results Reference
    background
    PubMed Identifier
    16214770
    Citation
    Forchielli ML, Walker WA. The effect of protective nutrients on mucosal defense in the immature intestine. Acta Paediatr Suppl. 2005 Oct;94(449):74-83. doi: 10.1111/j.1651-2227.2005.tb02159.x.
    Results Reference
    background
    PubMed Identifier
    10968793
    Citation
    Neish AS, Gewirtz AT, Zeng H, Young AN, Hobert ME, Karmali V, Rao AS, Madara JL. Prokaryotic regulation of epithelial responses by inhibition of IkappaB-alpha ubiquitination. Science. 2000 Sep 1;289(5484):1560-3. doi: 10.1126/science.289.5484.1560.
    Results Reference
    background
    PubMed Identifier
    17499603
    Citation
    Deshpande G, Rao S, Patole S. Probiotics for prevention of necrotising enterocolitis in preterm neonates with very low birthweight: a systematic review of randomised controlled trials. Lancet. 2007 May 12;369(9573):1614-20. doi: 10.1016/S0140-6736(07)60748-X.
    Results Reference
    background

    Learn more about this trial

    Role of Probiotics for Prevention of NEC in Preterm VLBW Infants

    We'll reach out to this number within 24 hrs