Overview

This trial is active, not recruiting.

Condition neonatal respiratory failure
Treatments nasal intermittent positive pressure ventilation (nippv), bi-level positive airway pressure (bipap)
Phase phase 3
Sponsor Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Start date December 2010
End date January 2011
Trial size 100 participants
Trial identifier NCT01318824, 2011002

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (caregiver)
Primary purpose treatment
Arm
(Placebo Comparator)
This group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment.
nasal intermittent positive pressure ventilation (nippv) Nasal Intermittent Positive Pressure Ventilation
The Control group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment
(Experimental)
This group receive Bi-Level Positive Airway Pressure (BIPAP) treatment
bi-level positive airway pressure (bipap) Bi-Level Positive Airway Pressure
BiPAP group receive Bi-Level Positive Airway Pressure (BIPAP) treatment

Primary Outcomes

Measure
the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
time frame: At 7 days, 28 days and at 36 weeks postmenstraul age

Secondary Outcomes

Measure
the effect of Versus Bi-Level Positive Airway Pressure (BIPAP) for Neonatal Respiratory Failure
time frame: At 7 days, 28 days and at 36 weeks postmenstraul age

Eligibility Criteria

Male or female participants up to 28 days old.

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

Additional Information

Official title A Study of Bi-Level Positive Airway Pressure (BIPAP) Versus Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
Principal investigator Shifang Tang
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2011.
Information provided to ClinicalTrials.gov by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.