title: Role of prophylactic antibiotics in neonates born through meconium-stained amniotic fluid (MSAF)--a randomized controlled trial.
abstract: The objective of the study was to evaluate the effect of administering prophylactic antibiotics on the development of neonatal sepsis in term neonates born through meconium-stained amniotic fluid (MSAF). Two hundred and fifty eligible neonates were randomized to study group (Antibiotic group-receiving first-line antibiotics for 3 days) and control group (No Antibiotic group). Both groups were evaluated clinically and by laboratory parameters (sepsis screen and blood cultures) for development of sepsis. All neonates were monitored for respiratory, neurological, and other systemic complications and received supportive treatment according to standard management protocol of the unit. One hundred and twenty one neonates were randomized to 'Antibiotic' group and 129 to 'No Antibiotic' group. The overall incidence of suspect sepsis was 9.6 % in the study population with no significant difference between 'No Antibiotic' and 'Antibiotic' groups (10.8 vs. 8.2 %, p = 0.48, odds ratio (OR) 0.74, 95 % confidence interval (CI) 0.32-1.73). Incidence of culture-proven sepsis was also not significantly different between the two groups (5.42 vs. 4.13 %, p = 0.63, OR 0.75, 95 % CI 0.23-2.43). The incidence of mortality, meconium aspiration syndrome, and other complications was comparable amongst the two groups.
  
  
  CONCLUSIONS
  Routine antibiotic prophylaxis in neonates born through MSAF did not reduce the incidence of sepsis in this study population. (Clinicaltrials.gov no. - NCT01290003).
authors.affiliation: Department of Pediatrics, Lady Hardinge Medical College and Kalawati Saran Children Hospital, New Delhi, India, ankitagoel.85@gmail.com.
authors.forename: Ankita
authors.initials: A
authors.lastname: Goel
authors.forename: Sushma
authors.initials: S
authors.lastname: Nangia
authors.forename: Arvind
authors.initials: A
authors.lastname: Saili
authors.forename: Akanksha
authors.initials: A
authors.lastname: Garg
authors.forename: Sunita
authors.initials: S
authors.lastname: Sharma
authors.forename: V S
authors.initials: VS
authors.lastname: Randhawa
mesh_terms: D000583:Amikacin / Q000008:administration & dosage; D000653:Amniotic Fluid; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D019072:Antibiotic Prophylaxis / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007262:Infusions, Intravenous; D008297:Male; D008470:Meconium / Q000382:microbiology; D008471:Meconium Aspiration Syndrome / Q000453:epidemiology / Q000517:prevention & control*; D010397:Penicillanic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives; D010878:Piperacillin / Q000008:administration & dosage; D000077725:Piperacillin, Tazobactam Drug Combination; D011247:Pregnancy; D011446:Prospective Studies; D018805:Sepsis / Q000517:prevention & control*
chemical_list: D000900:Anti-Bacterial Agents; D000077725:Piperacillin, Tazobactam Drug Combination; D000583:Amikacin; D010397:Penicillanic Acid; D010878:Piperacillin
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