Observational Crossover Study Comparing Oxygenation and Ventilation Using SiPAP Versus CPAP in LBW 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

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-05-31

Brief Summary

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

Investigation of effects of SiPAP versus NCPAP on oxygenation and ventilation in LBW infants with respiratory distress. Our hypothesis is that the LBW infants will achieve the same level of oxygenation and improved ventilation when being treated with SiPAP as compared to NCPAP.

Related Clinical Trials

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

CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure

NCT03670732

Prematurity Respiratory Distress Syndrome Apnea of Prematurity

TERMINATED 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

A Study of Bi-Level Positive Airway Pressure (BIPAP) Versus Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure

NCT01318824

Neonatal Respiratory Failure

UNKNOWN PHASE3

Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants

NCT06295484

Preterm Birth Premature Lungs Respiratory Distress Syndrome in Premature Infant

RECRUITING NA

Comparison of Continuous Positive Airway Pressure and Non Invasive Positive Pressure Ventilation

NCT03347136

Respiratory Distress of Newborn

COMPLETED NA

Detailed Description

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

Conditions

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

Ventilation Respiratory Distress Syndrome

Study Design

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

Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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

Starting on NCPAP

randomized to start on NCPAP

SiPAP

Intervention Type DEVICE

biphasic CPAP (SiPAP) to be alternated in 1 hour blocks with NCPAP

Starting on SiPAP

randomized to SiPAP

SiPAP

Intervention Type DEVICE

biphasic CPAP (SiPAP) to be alternated in 1 hour blocks with NCPAP

Interventions

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

SiPAP

biphasic CPAP (SiPAP) to be alternated in 1 hour blocks with NCPAP

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

1. LBW infant (birth weight \<2500 grams)
2. Currently on nasal CPAP
3. Use of nasal CPAP for \>24 hours prior to study initiation
4. If history of intubation with mechanical ventilation, patient will be extubated \>24 hours prior to study initiation
5. FiO2 requirement of 25-50%

Exclusion Criteria

1. FiO2 requirement \>0.5
2. Congenital defects/deformities of the head, pulmonary or cardiovascular systems
3. Chromosomal abnormalities/genetic syndromes
4. Active medical treatment for symptomatic PDA
5. Active medical treatment for culture proven sepsis
6. Within 24 hours of invasive surgical procedure

Eligible Sex

ALL

Accepts Healthy Volunteers

No