Trial | NCT02650869  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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.
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.
Study Started
Jul 31
2012
Primary Completion
Dec 31
2015
Study Completion
Dec 31
2015
Last Update
Jan 08
2016
Estimate

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)

  • Other names: TS 6 Probiotics

Dietary Supplement Breast milk

Normal breast milk will be given as part of standard care

Standard care + Breast milk+ Probiotics Experimental

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.

Standard care Active Comparator

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

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
No Results Posted