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

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-02-28

Brief Summary

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

To research the effect of Bi-Level Positive Airway Pressure (BiPAP) for neonatal respiratory failure.

Related Clinical Trials

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

Bi-level Positive Airway Pressure for Respiratory Distress Syndrome in Twins Infants

NCT03235661

nCPAP BiPAP Respiratory Distress Syndrome

UNKNOWN NA

Nasal Intermittent Positive Pressure Ventilation(NIPPV) vs Continuous Positive Airway Pressure for Respiratory Distress Syndrome

NCT03226977

Nasal Intermittent Positive Pressure Ventilation Nasal Continuous Positive Airway Pressure

UNKNOWN NA

Nasal Intermittent Positive Pressure Ventilation In Newborn Infants With Respiratory Distress Syndrome

NCT00780624

Respiratory Distress Syndrome

COMPLETED NA

Nasal Intermittent Positive-Pressure Ventilation for Twin Infants With Respiratory Distress Syndrome

NCT01926106

Neonatal Respiratory Distress Syndrome

COMPLETED NA

Work of Breathing During Non-invasive Ventilation in Premature Neonates

NCT02788110

Respiratory Distress Syndrome, Newborn Bronchopulmonary Dysplasia

COMPLETED NA

Detailed Description

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

Bi-Level Positive Airway Pressure(BiPAP) is similar to Non Invasive Positive Pressure Ventilation (NIPPV), but also gives some breaths, or extra support, to newborn infants through a small tube in the nose. BiPAP is safe and effective. Nevertheless, BiPAP has never been used in Chinese babies.

Conditions

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

Neonatal Respiratory 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

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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

I=NIPPV

This group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment.

Group Type PLACEBO_COMPARATOR

Nasal Intermittent Positive Pressure Ventilation (NIPPV)

Intervention Type PROCEDURE

The Control group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment

II=BiPAP

This group receive Bi-Level Positive Airway Pressure (BIPAP) treatment

Group Type EXPERIMENTAL

Bi-Level Positive Airway Pressure (BIPAP)

Intervention Type PROCEDURE

BiPAP group receive Bi-Level Positive Airway Pressure (BIPAP) treatment

Interventions

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

Nasal Intermittent Positive Pressure Ventilation (NIPPV)

The Control group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment

Intervention Type PROCEDURE

Bi-Level Positive Airway Pressure (BIPAP)

BiPAP group receive Bi-Level Positive Airway Pressure (BIPAP) treatment

Intervention Type PROCEDURE

Other Intervention Names

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

Nasal Intermittent Positive Pressure Ventilation Bi-Level Positive Airway Pressure

Eligibility Criteria

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

Inclusion Criteria

1. Newborn infants with birth weight \> 500 gm.
2. Gestational age \> 24 completed weeks.
3. Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either: the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.
4. No known lethal congenital anomaly or genetic syndromes.
5. Signed parental informed consent.

Exclusion Criteria

1. Considered non-viable by clinician (decision not to administer effective therapies)
2. Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
3. Infants known to require surgical treatment
4. Abnormalities of the upper and lower airways
5. Neuromuscular disorders
6. Infants who are \> 28 days old and continue to require mechanical ventilation with an endotracheal tube

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No