A Comparative Study Between Postextubation of Preterm Infants Into High-Flow Nasal Cannulae V.S Nasal Continuous Positive Airway Pressure

Study Overview
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Brief Summary
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The investigators hypothesize that there is a growing trend of the feasibility of HFNC as an alternative to other forms of non-invasive ventilation mechanism to provide continuous distending pressure to preterm infants. However, there remains uncertainty about the efficacy and safety of HFNC in this population.

Detailed Description
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Our primary outcome is to determine whether postextubation respiratory support via heated humidified high-flow nasal cannula results in a greater proportion of infants younger than 34 weeks gestation being successfully extubated after a period of endotracheal positive pressure ventilation compared with conventional (NCPAP). The following study will be conducted in the neonatal intensive care unit (NICU) of Gynecology and Obstetric department of Kasr El Aini hospital and neonatal intensive care unit of Military Hospital throughout a time interval of at least 6 months for a minimum of 100 preterm infants. Infants will be eligible for the study if they born at less than 34 weeks' gestation, required endotracheal intubation and positive pressure ventilation, and considered ready for extubation by the clinical team. The investigators will assign extubation of preterm ventilated infants (50 preterm infant) in NICU of Military Hospital into HHFNC and extubation of preterm ventilated infants (50 preterm infant) in (NICU) of Gynecology and Obstetric department of Kasr El Aini hospital into NCPAP (50 preterm infant).

Official Title
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A Comparative Study Between Postextubation of Preterm Infants Into High-Flow Nasal Cannulae V.S Nasal Continuous Positive Airway Pressure

Conditions
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Neonatal Respiratory Distress

Intervention / Treatment
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* Device: High flow nasal cannula vs. Nasal continuous positive airway pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: •Infants born at a gestational age of less than 34 weeks, receiving mechanical ventilation through an endotracheal tube. Exclusion Criteria: Full term neonates or large for gestational age. Preterm neonates not supported primarily by invasive ventilation. Infants with suspected upper airway obstruction, congenital airway malformations or major cardiopulmonary malformations.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm neonates on HFNC<br>neonates extubated to HFNC (High flow nasal cannula) | Device: High flow nasal cannula vs. Nasal continuous positive airway pressure<br>* High flow nasal cannula<br>|
| Preterm neonates on NCPAP<br>neonates extubated to NCPAP ( nasal continuous positive airway pressure) | Device: High flow nasal cannula vs. Nasal continuous positive airway pressure<br>* High flow nasal cannula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postextubation respiratory support | compare successful extubation of preterm (less than 34 weeks) into high flow nasal cannula versus continues positive airway pressure. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postextubation respiratory support follow up | Secondary outcomes include the following: Need for delayed reintubation (beyond 7 days) Incidence of bronchopulmonary dysplasia. Total number of days of hospital stay. | through study completion, an average of 1 year |