Level of Continuous Positive Airway Pressure (CPAP) in Preterm Infants After Extubation (L-CPAP Study)

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-06-30

Brief Summary

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

Despite widely used of nasal CPAP in preterm infants, uncertainties regarding aspects of its application remain. Clinical indications vary greatly between institutions, especially when combined with varieties of systems, devices, and techniques available. One of the controversial aspects that needs to be clarified is the level of pressure which should be used. The objective of the study is to compare the effectiveness of two ranges of nCPAP pressure that are within the spectrum of current practice for post-extubation support in very preterm infants.

Related Clinical Trials

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

Infant Pulmonary Mechanics: High Flow Nasal Cannula Versus Nasal CPAP

NCT01939067

Respiratory Distress Lung Injury

WITHDRAWN PHASE1

Optimal High CPAP Pressures in Preterm Neonates Post-extubation

NCT05230485

Preterm Birth Mechanical Ventilation Complication Respiratory Distress Syndrome, Newborn

UNKNOWN NA

Oscillatory Versus Non-oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support

NCT03711565

Neonatal Respiratory Distress Related Conditions

WITHDRAWN NA

A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation

NCT03292562

Apnea of Prematurity Respiratory Distress Syndrome

COMPLETED NA

Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support

NCT01277874

Respiratory Distress Syndrome Prematurity

WITHDRAWN NA

Detailed Description

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

The use of nCPAP has been established as an effective respiratory support to prevent extubation failure and as treatment of other pulmonary diseases. An upsurge in its popularity has resulted in some controversial aspects, including the level of pressure to be used. The level that has been used in very preterm infants after extubation, which mostly came from anecdotal data, varies from 3 to 10 cmH2O.

Physiologic studies show higher nCPAP pressures improve lung mechanical properties. Though potential side effects have been of concern in practical application, there is no formal evidence supporting the concept that increased CPAP pressure results in a higher risk of complications. In relatively stable preterm infants, the range of optimal CPAP level needs to be established in order to adequately support the upper airway and lungs, without increasing complications secondary to the pressure applied. Given the uncertainty of the nCPAP pressure that should be used in very preterm infants, we conduct a randomized controlled trial to compare the effectiveness of two ranges of nCPAP pressure for post-extubation support in very preterm infants.

The purpose of this trial is to compare the rate of successful extubation of using the nasal CPAP level of 7 to 9 cmH2O compared to level of 4 to 6 cmH2O.

Conditions

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

Respiratory Insufficiency of Prematurity

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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

1

Nasal CPAP, level of 7 to 9 cmH2O

Group Type EXPERIMENTAL

Nasal CPAP, level 7 to 9 cmH2O

Intervention Type DEVICE

Apply nasal CPAP pressure of 7-9 H2O for the first 72 hours of extubation

2

Nasal CPAP, level 4 to 6 cmH2O

Group Type ACTIVE_COMPARATOR

Nasal CPAP, level 4 to 6 cmH2O

Intervention Type DEVICE

Apply nasal CPAP pressure of 4 to 6 cmH2O for the first 72 hours of extubation

Interventions

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

Nasal CPAP, level 7 to 9 cmH2O

Apply nasal CPAP pressure of 7-9 H2O for the first 72 hours of extubation

Intervention Type DEVICE

Nasal CPAP, level 4 to 6 cmH2O

Apply nasal CPAP pressure of 4 to 6 cmH2O for the first 72 hours of extubation

Intervention Type DEVICE

Other Intervention Names

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

High pressure nCPAP, 7-9 cmH2O Low pressure CPAP, 4-6 cmH2O

Eligibility Criteria

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

Inclusion Criteria

* Birth weight 500 - 1,250 g
* On mechanical ventilation before 7 days of age
* First extubation before 14 days of age

Exclusion Criteria

* Presence of lethal anomalies or upper airway abnormalities
* IVH, grade 3 or 4
* Neuromuscular disorders
* Receiving muscle relaxation at time of extubation
* Congenital heart disease, except for PDA
* GI problems resulting in a need to avoid gastric distension

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No