Role of Probiotic Use in Outcomes of Premature Birth

Project Summary:The prevalence of preterm birth ranges from 5% to 18% across 184 countries, and an estimated 15 million infants are born preterm globally. These infants with an immature immune system and gastrointestinal tract are at risk of complications of premature birth, which is the leading cause of neonatal death. According to researcher hypothesis for this study, there is role of probiotics in promoting food tolerance and reducing the incidence and severity of Necrotizing Enterocolitis (NEC) and death related to NEC in pre-term VLBW infants. In the current study, we will examine the effects of probiotics in premature infants and figure out the optimal intervention through randomized controlled trial (RCT).A prospective, masked, randomized single blinded controlled trial will be conducted in the neonatal intensive care unit (NICU) of Services Hospital Lahore. In this trial the treatment group will receive the probiotics during their first month of life, and the control group will receive no treatment. Primary outcome will be the incidence of death or NEC (≥ stage 2). Death is included as a primary outcome because it is a competing variable of NEC. The x2 test will be used to analyze the categorical data, along with Fisher's exact test when applicable. The Student's t test will be used for continuous data. A logistic regression model will be used to analyze the treatment effects on the primary and secondary outcome variables (death, NEC, and sepsis). Values will be expressed for mean and standard deviation. Statistical significance is set at P-value of 0.05.The objective of this study is to confirm the evidence and to get the more reliable and authentic results regarding the more effective treatment of NEC in preterm neonates. In this way, we shall be able to improve the outcome of premature births and to reduce the complications by increasing the cure rate. Similarly, it will help us to improve our knowledge for better management of NEC in neonates.

Inclusion Criteria:Premature infants with gestational age of more than 28 weeks and less than 36 weeksBirth weight of 1000 - 2500 gramsAdmitted to the neonatal intensive care unit (NICU) of Pediatric Medicine Unit II, Services hospital LahoreWith intestinal feeding.Exclusion Criteria:Infants with major congenital malformations (including congenital heart disease, gastrointestinal obstruction, gastroschisis, etc.)Congenital metabolic errors hypoxic ischemic encephalopathy (HIE) of grade two or more according to Sarnat scoring system (Gordon et al., 2020)Death in the first 72 hours of lifeNewborns of addicted mothersPostpartum age more than two weeksParental unacceptance