Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator

Study Overview
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Brief Summary
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Very premature infants often cannot breathe on their own and require assistance with a respirator. Conventional respirators deliver air or oxygen via a breathing tube placed through the mouth to the airway (endotracheal tube). A prolonged use of an endotracheal tube is associated with injury to the lungs. Currently, a premature baby has to be ventilated through an endotracheal tube until he/she can fully breathe independently. In the current study, in order to shorten the time with an endotracheal tube, we utilized an alternative, less invasive ventilation procedure, nasal intermittent positive pressure ventilation (NIPPV). This procedure provides help with breathing, but requires only nasal, not endotracheal tubes. We hypothesized that NIPPV might help babies breathe, at an early stage in their recovery, when they could not breathe independently yet. Thus, by switching babies at this early stage from a regular respirator to NIPPV, we should be able to shorten the use of an injurious endotracheal tube.

Official Title
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Nasal Intermittent Positive Pressure Ventilation Allows Early Extubation In Infants Less Than 28 Weeks Gestation: A Pilot Study

Conditions
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Bronchopulmonary Dysplasia

Intervention / Treatment
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* Procedure: Extubation to NIPPV
* Procedure: Extubation to CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age 24 wks and 0 days through 27 wks and 6 days by obstetric criteria. Infants who are intubated for respiratory distress and received surfactant within 48 hrs of life. Infants whose ventilator settings are: ventilatory rate ≥ 26 breaths per minute. If the baby is on the high frequency oscillatory ventilator (HFOV) settings are MAP(mean airway pressure) ≥ 9, amplitude ≥ 2xMAP and frequency ≤ 13 Hertz. Infants who have never been previously extubated. Exclusion Criteria: Infants enrolled in competing trials. Participation refused by parent/attending physician/ parent unavailable for consent. Infants with any major congenital abnormality. Postoperative patients from any surgery. Infants in extremis/decided upon not to receive intensive care. Ventilator settings lower than the intervention group.

Ages Eligible for Study
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Maximum Age: 48 Hours

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIPPV<br>Extubation to NIPPV (nasal intermittent positive pressure ventilation) | Procedure: Extubation to NIPPV<br>* After extubation infants were placed on NIPPV as soon as all the extubation criteria were met<br>* Other names: NIPPV;|
| Active Comparator: CPAP<br>After extubation this arm was placed on CPAP (continuous positive airway pressure) and was not offered NIPPV in the first month on life | Procedure: Extubation to CPAP<br>* After extubation infants were placed on CPAP<br>* Other names: CPAP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days Being Intubated |  | 30 days from birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Reintubation | Reintubation rate is a measure of the efficacy of NIPPV. | 0-7 days post-extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiration, Artificial, Infant, Premature, Bronchopulmonary Dysplasia, Continuous Positive Airway Pressure, Non-Invasive Positive-Pressure Ventilation, Intermittent Positive-Pressure Ventilation, High-Frequency Ventilation