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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Lady Hardinge Medical College
Sponsor:
Information provided by (Responsible Party):
Sushma Nangia, M.D., Lady Hardinge Medical College
ClinicalTrials.gov Identifier:
NCT01290003
First received: February 3, 2011
Last updated: December 23, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Neonatal Sepsis
Drug: Piperacillin-Tazobactam and Amikacin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Role of Prophylactic Antibiotics in Preventing Neonatal Sepsis in Neonates Born Through Meconium Stained Amniotic Fluid - A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Lady Hardinge Medical College:

Primary Outcome Measures:
  • Incidence of sepsis [ Time Frame: First 28 days of life ] [ Designated as safety issue: No ]

    Incidence of sepsis in first 28 days defined as -

    1. SUSPECTED SEPSIS - Sepsis Screen > 2 parameters positive and/or
    2. CONFIRMED SEPSIS - Sepsis Screen positive + Blood or CSF culture positive for bacteria.

    Sepsis Screen

    1. Total leukocyte count < 5000/mm3
    2. Absolute neutrophil count < 1800/cu.mm.(Low counts as per Monroe chart for term neonates)
    3. Immature/total neutrophil ratio > 0.2
    4. Micro-ESR > 15mm in 1st hour
    5. C Reactive Protein (CRP) > 1 mg/dl


Secondary Outcome Measures:
  • Mortality; [ Time Frame: First 28 days of life ] [ Designated as safety issue: No ]
  • Respiratory support; [ Time Frame: Till discharge from the hospital ] [ Designated as safety issue: No ]
    1. Requirement of respiratory support
    2. The mode of respiratory support viz. Supplemetal Oxygen therapy, CPAP, Mechanical ventilation, High Frequency ventilation
    3. Duration of each kind of respiratory support required

  • Duration of Hospital stay [ Time Frame: Till discharge ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: Till discharge ] [ Designated as safety issue: No ]
    Incidence of PPHN by Echocardiography, Pneumothorax by transillumination confirmed by chest x-ray, azotemia by Kidney function test panel


Estimated Enrollment: 250
Study Start Date: June 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Antibiotic Group
Neonates randomized to 'No antibiotic group' will receive supportive treatment as per standard unit protocol. These neonates will be monitored by performing sepsis screens and blood culture for development of sepsis.
Experimental: Antibiotic Group
Neonates randomized to intervention Group(Antibiotic group)will receive the first line antibiotics as per the unit policy for 72 hours. These neonates will also be monitored by performing sepsis screens and blood culture for development of sepsis.
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)

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

Ages Eligible for Study:   up to 2 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Major Congenital malformation
  • Refusal of consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290003

Locations
India
Kalawati Saran children's Hospital, Lady Hardinge Medical College Recruiting
New Delhi, Delhi, India, 110001
Contact: Sushma Nangia, MBBS,MD,DM    09810838181    drsnangia@gmail.com   
Contact: Arvind Saili, MBBS, MD    09868117699    sailiarvind@gmail.com   
Sub-Investigator: Ankita Goel, MBBS         
Principal Investigator: Sushma Nangia, MBBS,MD,DM         
Sponsors and Collaborators
Lady Hardinge Medical College
Investigators
Study Chair: Sushma Nangia, MBBS, MD, DM Lady Hardinge Medical College, New Delhi, India
  More Information

No publications provided

Responsible Party: Sushma Nangia, M.D., Professor Pediatrics, Lady Hardinge Medical College
ClinicalTrials.gov Identifier: NCT01290003     History of Changes
Other Study ID Numbers: LHMC/054/Ab-Pro-M
Study First Received: February 3, 2011
Last Updated: December 23, 2012
Health Authority: India: Indian Council of Medical Research

Keywords provided by Lady Hardinge Medical College:
Antibacterial agents
Neonate
Meconium stained amniotic fluid
Neonatal sepsis

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Amikacin
Anti-Bacterial Agents
Piperacillin
Piperacillin-tazobactam combination product
Penicillanic Acid
Antibiotics, Antitubercular
Tazobactam
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014