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Completed

NCT Number: NCT00979433

Bubble Continuous Positive Airway Pressure (CPAP) With Conventional CPAP for Extubation in Preterm Infants

The objective of this study is to evaluate whether CPAP delivered by bubble CPAP resulted in a greater proportion of infants being successfully extubated when compared with management with ventilator derived CPAP.

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Key information

Conditions

Extubation Failure

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

About this study

There have been no published randomized trials comparing extubation failure rates of Bubble CPAP with conventional ventilator derived CPAP. Infants of gestation <32 weeks and of birth weight less than 1500 grams considered by the treating team to be ready for the initial extubation within first week of life were screened for enrolment. All eligible neonates were randomly allocated to bubble CPAP or conventional CPAP.The purpose of this study is to compare whether infants on Bubble CPAP had more chances of successful extubation as compared to infants put on Conventional CPAP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestation less than 32 weeks
  • Birth weight less than 1500 g
  • Age less than seven days
  • First extubation attempt.

Exclusion criteria

  • A neonate having any of the following will be excluded from the study-
  • Severe birth asphyxia defined as need for chest compression for more than 30 seconds
  • Suspected congenital neuromuscular disorder
  • Major congenital malformation
  • Grade 3/4 interventricular haemorrhage
  • Hydrops.

Treatment and study plan

Bubble CPAP

Device

Bubble CPAP will be delivered using Fischer & Paykel CPAP system with a starting flow of 6 liters/minute. CPAP will be initially started at a pressure of 5 - 6 cm H2O and fraction of inspired oxygen (FiO2) of 0.4 - 0.5. which will be adjusted to maintain oxygen saturation (SpO2) between 87 and 93%.

Other names: Fisher & Paykel Bubble CPAP System

Conventional CPAP

Device

Conventional CPAP will be delivered using Argyle CPAP (Sherwood Medical Company, Mexico) short nasal prongs with warm, humidified gas used (34-37°C) through a thermo-statically controlled humidifier, flow @ 4-8 L/min from either SLE 2000 pressure-controlled continuous flow ventilator (Specialized Laboratory Equipment, UK) or Baby log 8000 volume guarantee ventilator.

Primary outcomes

  1. Extubation failure - defined as need for reintubation and mechanical ventilation for any reason within 72 hours of initial extubation

    Time frame: Till 72 hours after extubation

Secondary outcomes

  1. Time to extubation failure in hours.

    Time frame: till extubation failure within first 72 hours after extubation

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Official study title

Bubble CPAP vs. Conventional CPAP Following Extubation in Preterm Very Low Birth Weight (VLBW) Infants: A Randomized Controlled Trial

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 18, 2009
Registry last updated
Feb 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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