Clinical Trial: The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis Among Very Low Birth Weight Infants With Formula-feeding
Brief Summary: The purpose of this study is to investigate the efficacy and its mechanisms of oral mixture probiotics in preventing necrotizing enterocolitis among the preterm very low birth weight infants.
Detailed Summary:
Necrotizing enterocolitis (NEC) remains the most catastrophic gastrointestinal emergencies in preterm very low birth weight (VLBW) infants.Although study showed it is a multifactorial disease, its pathogenesis is still not yet unclear currently. Prematurity and formula feeding is considered as the main risk factors.Gut microbiota disturbance and immature immune system is associated with NEC. A lot of studies had showed that oral probiotics can alter gut microbiota flora colonization and reduce the incidence of NEC,but the exact mechanism remains unclear.The aim of this study is to elucidate the clinical efficacy and possible molecular mechanism of oral mixture probiotics in preventing NEC among preterm VLBW infants.
Patient Registry procedures: First,randomized numbers was generated by the computer and sent to the principal investigator(PI) at each center when an infant was eligible for enrollment.Second, patient will be assigned randomly to experimental group or control group by PI.Finally,the PI at each center will be responsible for the accuracy,completeness or representativeness of medical records, registry forms,data collection.
Sample size determination: The incidence of death and NEC was around 20% recently.To reduce the incidence of NEC and death to 10% at discharge would require a 50% improvement.At 80% power at P = 0.05 (two-sided),the loss rate of 0.2, this would require 135 subjects per arm.
Statistical analysis:The two groups were compared by a Χ2-test for categorical variables,Mann-Whitney U Test were used when reporting medians.A P value of <0.05 was considered statistically significant.
Sponsor: Shenzhen Bao'an Maternal and Child Health Hospital
Current Primary Outcome: the incidence of combined death and necrotizing enterocolitis [ Time Frame: at 36 weeks correct gestational age ]
Original Primary Outcome: Same as current
Current Secondary Outcome: the incidence of sepsis,intraventricular hemorrhage(IVH)(grade 3-4),feeding intolerance(FI),bronchopulmonary dysplasia(BPD),parenteral nutrition associated liver disease(PNALD)and retinopathyof prematurity(ROP). [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 8 weeks ]
Original Secondary Outcome: Same as current
Information By: Shenzhen Bao'an Maternal and Child Health Hospital
Dates:
Date Received: September 12, 2015
Date Started: September 2014
Date Completion: September 2017
Last Updated: March 26, 2016
Last Verified: September 2015
