Role of Probiotics for Prevention of NEC in Preterm VLBW Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Role of Probiotics for Prevention of Necrotizing Enterocolitis in Preterm Very Low Birth Weight Infants: A Double Blind Randomized Controlled Trial

Conditions
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Necrotizing Enterocolitis

Intervention / Treatment
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* Dietary Supplement: Probiotics
* Dietary Supplement: Breast milk


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 33 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard care + Breast milk+ Probiotics<br>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. | Dietary Supplement: Probiotics<br>* 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)<br>* Other names: TS 6 Probiotics;|
| Active Comparator: Standard care<br>The control group will be given standard care without the addition of probiotics | Dietary Supplement: Breast milk<br>* Normal breast milk will be given as part of standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enteral feeding | days to achieve full enteral feeding | 10 days | 
| Hospital stay | maximum days of hospital stay | 10 days | 
| weight in Kg | weight in kg | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Necrotizing Enterocolitis, probiotics, very low birth weight