Role of Probiotics for Prevention of NEC in Preterm VLBW Infants

Sylhet M.A.G.Osmani Medical College

Status and phase: Completed; Phase 3

Conditions: Necrotizing Enterocolitis

Treatments: Dietary Supplement: Breast milk; Dietary Supplement: Probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT02650869

SylhetMAG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 1 to 33 weeks old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Standard care + Breast milk+ Probiotics

Experimental group

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.

Treatment:

Dietary Supplement: Probiotics

Standard care

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Breast milk