Role of Antibiotics in Preventing Infection in Babies Born Through Meconium Stained Liquor

Neonatal Sepsis Clinical Trial

— AbProM  

Official title:

Role of Prophylactic Antibiotics in Preventing Neonatal Sepsis in Neonates Born Through Meconium Stained Amniotic Fluid - A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01290003
• Other study ID #: LHMC/054/Ab-Pro-M
• Status: Completed
• Phase: N/A
• First received: February 3, 2011
• Last updated: September 26, 2015
• Start date: June 2010
• Est. completion date: January 2011

Study information

• Verified date: September 2015
• Source: Lady Hardinge Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Hours

Eligibility

Inclusion Criteria:

• Gestation > 37 weeks

• Meconium staining of amniotic fluid

• Cephalic presentation

• Singleton pregnancy

Exclusion Criteria:

• Major Congenital malformation

• Refusal of consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neonatal Sepsis
• Sepsis

Intervention

Drug:
• Piperacillin-Tazobactam and Amikacin
Inj Piperacillin-Tazobactam 50 mg/Kg/dose 12 hourly IV X 3 days (6 doses) Inj Amikacin 15 mg/kg/dose 24 hourly IV X 3 days (3 doses)

Locations

Country	Name	City	State
India	Kalawati Saran children's Hospital, Lady Hardinge Medical College	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Lady Hardinge Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of sepsis	Incidence of sepsis in first 28 days defined as -; SUSPECTED SEPSIS - Sepsis Screen > 2 parameters positive and/or; CONFIRMED SEPSIS - Sepsis Screen positive + Blood or CSF culture positive for bacteria.; Sepsis Screen; Total leukocyte count < 5000/mm3; Absolute neutrophil count < 1800/cu.mm.(Low counts as per Monroe chart for term neonates); Immature/total neutrophil ratio > 0.2; Micro-ESR > 15mm in 1st hour; C Reactive Protein (CRP) > 1 mg/dl	First 28 days of life	No
Secondary	Mortality;		First 28 days of life	No
Secondary	Respiratory support;	Requirement of respiratory support; The mode of respiratory support viz. Supplemetal Oxygen therapy, CPAP, Mechanical ventilation, High Frequency ventilation; Duration of each kind of respiratory support required	Till discharge from the hospital	No
Secondary	Duration of Hospital stay		Till discharge	No
Secondary	Complications	Incidence of PPHN by Echocardiography, Pneumothorax by transillumination confirmed by chest x-ray, azotemia by Kidney function test panel	Till discharge	No