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

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

Detailed Description
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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.

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

Conditions
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Neonatal Respiratory Failure

Intervention / Treatment
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* Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV)
* Procedure: Bi-Level Positive Airway Pressure (BIPAP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newborn infants with birth weight > 500 gm. Gestational age > 24 completed weeks. 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. No known lethal congenital anomaly or genetic syndromes. Signed parental informed consent. Exclusion Criteria: Considered non-viable by clinician (decision not to administer effective therapies) Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis) Infants known to require surgical treatment Abnormalities of the upper and lower airways Neuromuscular disorders Infants who are > 28 days old and continue to require mechanical ventilation with an endotracheal tube

Ages Eligible for Study
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Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: I=NIPPV<br>This group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment. | Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV)<br>* The Control group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment<br>* Other names: Nasal Intermittent Positive Pressure Ventilation;|
| Experimental: II=BiPAP<br>This group receive Bi-Level Positive Airway Pressure (BIPAP) treatment | Procedure: Bi-Level Positive Airway Pressure (BIPAP)<br>* BiPAP group receive Bi-Level Positive Airway Pressure (BIPAP) treatment<br>* Other names: Bi-Level Positive Airway Pressure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure | get the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure | At 7 days, 28 days and at 36 weeks postmenstraul age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effect of Versus Bi-Level Positive Airway Pressure (BIPAP) for Neonatal Respiratory Failure | get the effect of Versus Bi-Level Positive Airway Pressure (BIPAP) for Neonatal Respiratory Failure | At 7 days, 28 days and at 36 weeks postmenstraul age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal Respiratory Failure, Newborn Infant, BiPAP, NIPPV