Clinical trial NCT02650869: Role of Probiotics for Prevention of NEC in Preterm VLBW Infants
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Necrotizing Enterocolitis
Keywords: Necrotizing Enterocolitis
probiotics
very low birth weight
Lead sponsor: Sylhet M.A.G.Osmani Medical College
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Necrotizing Enterocolitis: Occurrence of NEC (stage II and III) by Modified Bell's classification
timeFrame: 10 days
Secondary outcomes:
measure: Enteral feeding
timeFrame: 10 days
measure: Hospital stay
timeFrame: 10 days
measure: weight in Kg
timeFrame: 10 days
Other outcomes:
Locations:
Study officials:
affiliation: Professor and Head, Department of Paediatrics, Sylhet M.A.G.Osmani Medical College
name: Prof. M. Monojjir Ali, FCPS
role: STUDY_CHAIR
References:
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.
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.
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.
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.