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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Two Methods of Continuous Positive Airway Pressure (CPAP) to Support Successful Extubation of Infants of Birth Weights ≤ 1500 Grams (C2CPAP)

NCT00187434

Premature Birth Respiratory Insufficiency

UNKNOWN NA

Comparing Bubble and Ventilator Nasal CPAP in Preterm Infants

NCT02003846

Respiratory Distress Syndrome

COMPLETED

Novel Low Cost Bubble CPAP as an Alternative Respiratory Support in Low Resource Setting

NCT06082674

Premature Respiratory Distress Syndrome in Premature Infant

COMPLETED PHASE2

"Effectiveness of Delivery Room Bubble CPAP in Preterm Infants With Respiratory Distress

NCT07162285

Respiratory Distress Syndrome, Newborn

ENROLLING_BY_INVITATION NA

Delivery Room CPAP in Extremely Low Birth Weight Infants

NCT01223274

Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age +3 more

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Extubation Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bubble CPAP

All neonates randomised to bubble CPAP will be put on Bubble CPAP following initial extubation in first week of life.

Group Type EXPERIMENTAL

Bubble CPAP

Intervention Type 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%.

Conventional CPAP

All neonates randomly allocated to conventional/ventilator derived CPAP.

Group Type OTHER

Conventional CPAP

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bubble CPAP

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%.

Intervention Type DEVICE

Conventional CPAP

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fisher & Paykel Bubble CPAP System

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No