European Journal of Pediatrics

, Volume 174, Issue 2, pp 237–243 | Cite as

Role of prophylactic antibiotics in neonates born through meconium-stained amniotic fluid (MSAF)—a randomized controlled trial

  • Ankita Goel
  • Sushma NangiaEmail author
  • Arvind Saili
  • Akanksha Garg
  • Sunita Sharma
  • V. S. Randhawa
Original Article


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. Conclusion: Routine antibiotic prophylaxis in neonates born through MSAF did not reduce the incidence of sepsis in this study population. ( no. - NCT01290003)


Prophylactic antibiotics Neonatal sepsis Meconium-stained amniotic fluid 



Hypoxic ischemic encephalopathy


Meconium-stained amniotic fluid


Meconium aspiration syndrome


Persistent pulmonary hypertension of newborn


Urinary tract infection


Conflict of interest



This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.


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Copyright information

© Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  • Ankita Goel
    • 1
  • Sushma Nangia
    • 1
    Email author
  • Arvind Saili
    • 1
  • Akanksha Garg
    • 1
  • Sunita Sharma
    • 2
  • V. S. Randhawa
    • 3
  1. 1.Department of PediatricsLady Hardinge Medical College and Kalawati Saran Children HospitalNew DelhiIndia
  2. 2.Department of PathologyLady Hardinge Medical CollegeNew DelhiIndia
  3. 3.Department of MicrobiologyLady Hardinge Medical CollegeNew DelhiIndia

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