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
About this trial
This is an interventional treatment trial for Necrotizing Enterocolitis focused on measuring Necrotizing Enterocolitis, probiotics, very low birth weight
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
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
NCT ID
NCT02650869
First Posted
December 31, 2015
Last Updated
January 7, 2016
Sponsor
Sylhet M.A.G.Osmani Medical College
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
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Role of Probiotics for Prevention of NEC in Preterm VLBW Infants
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