Clinical trial NCT01290003: Role of Antibiotics in Preventing Infection in Babies Born Through Meconium Stained Liquor
Official title: Role of Prophylactic Antibiotics in Preventing Neonatal Sepsis in Neonates Born Through Meconium Stained Amniotic Fluid - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Sepsis
Keywords: Antibacterial agents
Neonate
Meconium stained amniotic fluid
Neonatal sepsis
Lead sponsor: Lady Hardinge Medical College
Sponsor class: OTHER_GOV
First posted: 2011-02-04
Enrollment: 250
Sex: ALL
Minimum age (years): 30
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate the role of antibiotics in preventing infection in babies born through meconium stained amniotic fluid. Normally babies do not pass meconium while in utero. In response to hypoxic stress babies may pass meconium before birth and are likely to be candidates for problems related to meconium passage and its inhalation. It is believed that these babies are more prone to infections as meconium enhances bacterial growth and may predispose such babies to secondary bacterial infections. In addition, meconium passage has been incriminated as a pointer of in-utero infection. Whether use of antibiotics in babies born through meconium stained amniotic fluid will reduce the infectious episodes and complications thereof or not is not clear. Moreover, there is not much published literature to prove or refute the same. Most clinicians have a low threshold for using antibiotics in such babies. In view of the uncertainty regarding antibiotic usage in these babies, the investigators decided to investigate the role of prophylactic antibiotics in prevention of neonatal sepsis in babies born through meconium stained amniotic fluid.

Detailed description: Meconium passage in newborn infants is a developmentally programmed event normally occurring within first 24-48 hours of birth. Intra uterine meconium passage in near term or term fetuses has been associated with feto-maternal stress factors and/or infections, whereas meconium passage in post term pregnancies has been attributed to gastro-intestinal maturity. The meconium staining of amniotic fluid occurs in 12% of all live births per annuum. Aspiration of meconium that occurs during intra uterine life or after delivery with the first few breaths may result in or contribute to respiratory pathology known as meconium aspiration syndrome (MAS) which represents a leading cause of the perinatal morbidity, occurring in 5-20% of all babies born through MSAF.

The routine use of antibiotics in MSAF babies has been advocated for a long time as a part of the conventional treatment. Meconium passage in utero is hypothesized to represent a response to fetal bacterial infection in addition to intrauterine hypoxia. Additionally the rationale for use of antibiotics includes the radiographic similarity of MAS to bacterial pneumonia, in vitro enhancement of bacterial growth in presence of meconium as well as the possibility of meconium induced inhibition of phagocytic activity and respiratory burst response by alveolar macrophages rendering patients with MAS more susceptible to infection. These recommendations however are empirical and the incidence of bacterial infection in neonates born through MSAF as well as in MAS has not been systematically evaluated, to date. With the rising concern about the emergence of resistant strains in neonatal ICUs and the possible side effects of antibiotics (like amino glycosides) including nephrotoxicity and ototoxicity in neonates, a systematically conducted, randomized controlled trial is necessary to assess the utility of antibiotics in the routine management of infants with MSAF and MAS. Hence the purpose of this prospective randomized controlled trial is to compare the clinical course, complications, and infection related outcomes in cases of MSAF and MAS, treated with or without antibiotics therapy

Eligibility criteria: Inclusion Criteria:

* Gestation \> 37 weeks
* Meconium staining of amniotic fluid
* Cephalic presentation
* Singleton pregnancy

Exclusion Criteria:

* Major Congenital malformation
* Refusal of consent

Primary outcomes:
measure: Incidence of sepsis
timeFrame: First 28 days of life
Secondary outcomes:
measure: Mortality;
timeFrame: First 28 days of life
measure: Respiratory support;
timeFrame: Till discharge from the hospital
measure: Duration of Hospital stay
timeFrame: Till discharge
measure: Complications
timeFrame: Till discharge
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Kalawati Saran children's Hospital, Lady Hardinge Medical College
state: Delhi
Study officials:
affiliation: Lady Hardinge Medical College, New Delhi, India
name: Sushma Nangia, MBBS, MD, DM
role: STUDY_CHAIR
References:
citation: Goel A, Nangia S, Saili A, Garg A, Sharma S, Randhawa VS. Role of prophylactic antibiotics in neonates born through meconium-stained amniotic fluid (MSAF)--a randomized controlled trial. Eur J Pediatr. 2015 Feb;174(2):237-43. doi: 10.1007/s00431-014-2385-4. Epub 2014 Aug 3.