Skip to main content
Clinical Trials/CTRI/2024/12/078760
CTRI/2024/12/078760
Not yet recruiting
Not Applicable

Clinical profile of neonates admitted in NICU with sepsis : A cross sectional study

DR ACHYUT RAMESH PATEL1 site in 1 country104 target enrollmentStarted: January 10, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
DR ACHYUT RAMESH PATEL
Enrollment
104
Locations
1
Primary Endpoint
● To study the clinical profile in neonate with sepsis

Overview

Brief Summary

Parents of all the neonates were invited to participate in the study. The study population consisted of all neonates admitted with a history and clinical features suggestive of neonatal sepsis, and attendants who gave consent to participate were enrolled in the study. For all the patients who gave consent to participate and met the inclusion criteria, a detailed maternal medical and obstetric history was obtained. Information regarding gestation, including complications during pregnancy, gestational age at delivery, mode of delivery, and birth weight, was recorded. A detailed history of the neonates suggestive of neonatal sepsis was taken. A comprehensive general and systemic examination of the neonates was performed, and neonatal risk factors were identified.

Sepsis screen investigations were conducted, which included:

Complete Blood Count (CBC), Micro ESR, C-reactive protein (CRP), Blood culture and antibiotic sensitivity, Immature/Total neutrophil ratio, Urine culture sensitivity, CSF culture and sensitivity (for suspected cases of meningitis), Absolute neutrophil count

These investigations were used to identify indicators suggestive of neonatal sepsis.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
1.00 Day(s) to 10.00 Day(s) (—)
Sex
All

Inclusion Criteria

  • All neonates with symptoms and clinical signs suggestive of sepsis, with or without maternal and/or neonatal risk factors.
  • Attendants of the neonates who gave informed consent.

Exclusion Criteria

  • Attendants of the neonates who did not give informed consent.
  • Neonates with apparent congenital anomalies.
  • Outborn neonates admitted to the NICU with a prior history of antibiotic treatment in the last 48 hours.

Outcomes

Primary Outcomes

● To study the clinical profile in neonate with sepsis

Time Frame: At baseline

OBJECTIVES

Time Frame: At baseline

● To identify causative organisms and study their antibiotic sensitivity pattern

Time Frame: At baseline

● To assess the correlation of perinatal and maternal risk factors in causation and outcome of neonatal sepsis

Time Frame: At baseline

Secondary Outcomes

  • Duration of hospital stay.(At discharge)

Investigators

Sponsor
DR ACHYUT RAMESH PATEL
Sponsor Class
Other []
Responsible Party
Principal Investigator
Principal Investigator

DR ACHYUT RAMESH PATEL

ROHILKHAND MEDICAL COLLEGE AND HOSPITAL

Study Sites (1)

Loading locations...

Similar Trials