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

A

All India Institute Of Medical Science (AIIMS)

Status

Completed

Conditions

Extubation Failure

Treatments

Device: Conventional CPAP
Device: Bubble CPAP

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full description

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.

Enrollment

32 patients

Sex

All

Ages

Under 7 days old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

32 participants in 2 patient groups

Bubble CPAP
Experimental group
Description:
All neonates randomised to bubble CPAP will be put on Bubble CPAP following initial extubation in first week of life.
Treatment:
Device: Bubble CPAP
Conventional CPAP
Other group
Description:
All neonates randomly allocated to conventional/ventilator derived CPAP.
Treatment:
Device: Conventional CPAP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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