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

Study Overview
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Brief Summary
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The submitted trial is the first prospective, randomized trial comparing nasal intermittent positive pressure ventilation(NIPPV) vs nCPAP in newborn infants with respiratory distress syndrome.

Detailed Description
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Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to newborn infants through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate standard therapy. Nevertheless, NIPPV has never been used in chinese babies. The submitted trial is the first prospective, randomized trial Comparing NIPPV vs nCPAP in newborn infants with respiratory distress syndrome.

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

Conditions
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Respiratory Distress Syndrome

Intervention / Treatment
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* Device: NIPPV
* Device: NIPPV
* Device: NIPPV


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: 1) 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; 2)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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Minimum Age: 1 Minute
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 |
| --- | --- |
| Active Comparator: NIPPV<br>The NIPPV group receiving NIPPV treatment. | Device: NIPPV<br>* Ventilator is Bird VIP.<br>Device: NIPPV<br>* Ventilator(Bird VIP) is used for NIPPV device. Non-invasive NIPPV is used in the NIPPV group instead of nCPAP in the control group.<br>Device: NIPPV<br>* Ventilator (Bird VIP, USA) is used for provide of NIPPV in the NIPPV group instead of nCPAP in the control group. The duration of NIPPV is according to the baby's respiratory condition.<br>|
| Active Comparator: Control<br>The Control group receiving nCPAP treatment. | Device: NIPPV<br>* Ventilator is Bird VIP.<br>Device: NIPPV<br>* Ventilator(Bird VIP) is used for NIPPV device. Non-invasive NIPPV is used in the NIPPV group instead of nCPAP in the control group.<br>Device: NIPPV<br>* Ventilator (Bird VIP, USA) is used for provide of NIPPV in the NIPPV group instead of nCPAP in the control group. The duration of NIPPV is according to the baby's respiratory condition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support. |  | At 7 days after non-invasive respiratorynsupport. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age. |  | 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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RDS, Infant, newborn, NIPPV, CPAP