Skip to main content
OpenTrials
Completed

NCT Number: NCT02650869

Role of Probiotics for Prevention of NEC in Preterm VLBW Infants

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

1 week–33 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotics

Dietary Supplement

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

breast milk

Dietary Supplement

Normal breast milk will be given as part of standard care

Primary outcomes

  1. Necrotizing Enterocolitis: Occurrence of NEC (stage II and III) by Modified Bell's classification

    Time frame: 10 days

    The occurrence of NEC (stage II and III) by modified Bell's classification

Secondary outcomes

  1. Enteral feeding

    Time frame: 10 days

    days to achieve full enteral feeding

  2. Hospital stay

    Time frame: 10 days

    maximum days of hospital stay

  3. weight in Kg

    Time frame: 10 days

    weight in kg

Sponsors and collaborators

Lead sponsor

Sylhet M.A.G.Osmani Medical College

Other

Registry information

Official study title

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

Acronym: Probiotics

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 8, 2016
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.