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

NCT01290003 | Completed DMC

• 1 other identifier: LHMC/054/Ab-Pro-M
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Sepsis

Keywords

Antibacterial agents; Neonate; Meconium stained amniotic fluid; Neonatal sepsis

Outcome Measures

Primary Outcomes (1)

• Incidence of sepsis

  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

  First 28 days of life

Secondary Outcomes (4)

• Mortality;

  First 28 days of life

• Respiratory support;

  Till discharge from the hospital

• Duration of Hospital stay

  Till discharge

• Complications

  Till discharge

Study Arms (2)

Antibiotic Group

EXPERIMENTAL

Neonates randomized to intervention Group(Antibiotic group)will receive the first line antibiotics (Piperacillin-Tazobactam and Amikacin) 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

No Antibiotic Group

NO INTERVENTION

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.

Interventions

Piperacillin-Tazobactam and Amikacin DRUG

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)

Antibiotic Group

Eligibility Criteria

• Age: 30 Minutes - 2 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Major Congenital malformation
• Refusal of consent

Sponsors & Collaborators

• Lady Hardinge Medical College: lead

Study Sites (1)

Kalawati Saran children's Hospital, Lady Hardinge Medical College

New Delhi, National Capital Territory of Delhi, 110001, India

Location

Related Publications (1)

• 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.

  PMID: 25084971 DERIVED

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Piperacillin, Tazobactam Drug Combination; Amikacin

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tazobactam; Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Piperacillin; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Sushma Nangia, MBBS, MD, DM

  Lady Hardinge Medical College, New Delhi, India

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Pediatrics

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 4, 2011
• Study Start: June 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: September 29, 2015

Record last verified: 2015-09

Locations

IN (1)