Status:

COMPLETED

Effectiveness of Bubble Nasal Continuous Positive Airway Pressure (bCPAP) in Neonatal Respiratory Distress

Lead Sponsor:

King Edward Medical University

Conditions:

Neonatal Respiratory Distress

Eligibility:

All Genders

1-28 years

Phase:

NA

Brief Summary

The objective of study is to determine the effectiveness of bubble Continuous Positive Airway Pressure (bCPAP) in neonates presenting with respiratory distress as compared to the control group ( using...

Detailed Description

After approval from the IRB of King Edward Medical University, and taking informed consent from parents of the participants, total of 120 neonates fulfilling inclusion and exclusion criteria will be e...

Eligibility Criteria

Inclusion

  • Patients having age 28 days of life or younger (Neonates)
  • Gender- both male and female
  • Gestational ages ≥32 weeks
  • Having respiratory distress (as per the operational definition- respiratory rate \>60/min plus any of the following features: grunting, subcostal/intercostal retractions, nasal flaring, inability to maintain spO2 \>90% at room air)
  • Silverman Anderson Retraction Score ≥4

Exclusion

  • Neonates having gestational age less than 32 weeks
  • Birth weight less than 1.5 kg
  • Neonates having congenital malformations, air leak syndromes, hypoxic ischemic encephalopathy
  • Neonates requiring mechanical ventilation at the time of admission

Key Trial Info

Start Date :

April 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 30 2018

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT04401696

Start Date

April 1 2017

End Date

June 30 2018

Last Update

May 26 2020

Active Locations (1)

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King Edward Medical University/ Mayo Hospital Lahore

Lahore, Punjab Province, Pakistan, 54000