High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure for Respiratory Support of Preterm Neonates

Study Overview
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Brief Summary
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This work is designed to: Evaluate the efficacy of HHHFNC in comparison with nCPAP in preterm neonates. Investigate hemodynamic changes associated with HHHFNC in comparison to nCPAP in preterm neonates during periods of non-invasive respiratory support and after being off support.

Detailed Description
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There is a preference of using noninvasive modes of ventilation for management of respiratory distress syndrome (RDS) in preterm infants and of weaning of ventilated neonates as soon as possible to non-invasive modes. Yet, little is known about which non-invasive mode is better and the hemodynamic changes that occur to the infants secondary to these modes. The study provides an evaluation of the efficacy of heated, humidified high flow nasal cannula (HHHFNC) in comparison to nasal continuous positive airway pressure (nCPAP) in preterm infants. Secondary aim is to assess echographic, cerebral blood flow and mesenteric blood flow changes during HHHFNC versus nCPAP.

Official Title
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Hemodynamic Changes With Heated, Humidified High Flow Nasal Cannula (HHHFNC) Versus Nasal Continuous Positive Airway Pressure (nCPAP) for Respiratory Support of Preterm Neonates

Conditions
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Respiratory Distress Syndrome, Newborn

Intervention / Treatment
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* Diagnostic Test: Functional Echocardiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants are eligible if they meet the following criteria: Gestational age ≤ 35 weeks. Preterm neonates in need for non invasive ventilation whether they were on invasive ventilatory support before or not. Exclusion Criteria: Preterm neonates with evidence of any of the following will be excluded: Major upper or lower airway anomalies. Significant congenital anomalies including cardiac, abdominal or respiratory. Hemodynamically significant patent ductus arteriosus (PDA): diagnosed if there is colour doppler echocardiographic evidence of left to right ductal shunt, ductal diameter >1.5mm/kg or left atrial/aortic root ratio >1.4

Ages Eligible for Study
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Maximum Age: 4 Weeks

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HHHFNC<br>it included 63 preterm neonates on Heated, Humidified High Flow Nasal Cannula, of which 35 preterm underwent functional echocardiography, transcranial ultrasonography Doppler applied to the anterior cerebral artery and assessment of pre-prandial superior mesenteric artery velocity and volume of blood flow with Doppler sonography. All of which done while on non invasive ventilation and after weaning. | Diagnostic Test: Functional Echocardiography<br>* Imaging studies to assess Hemodynamics of both groups on and off non invasive ventilation<br>* Other names: Assessment of pre-prandial superior mesenteric artery velocity and volume of blood flow with Doppler sonography;|
| NCPAP<br>it included 60 preterm neonates on Nasal Continuous Positive Airway Pressure, of which 35 preterm underwent functional echocardiography, transcranial ultrasonography Doppler applied to the anterior cerebral artery and assessment of pre-prandial superior mesenteric artery velocity and volume of blood flow with Doppler sonography. All of which done while on non invasive ventilation and after weaning. | Diagnostic Test: Functional Echocardiography<br>* Imaging studies to assess Hemodynamics of both groups on and off non invasive ventilation<br>* Other names: Assessment of pre-prandial superior mesenteric artery velocity and volume of blood flow with Doppler sonography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiography study for preterm neonates among the two study groups while on and off non invasive ventilation. | Done using Bedside functional echocardiography to record Superior vena caval flow (ml/kg/min), right ventricular output flow (ml/kg/min) and left ventricular output flow (ml/kg/min) for each preterm neonate in one of the two study groups (using either HHHFNC and nCPAP) on and off respiratory support. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy of HHHFNC in comparison with nCPAP in preterm neonates. | The percentage of success and failure among the HHHFNC and nCPAP groups , success defined as the preterm neonate that will not require invasive ventilation, while failure as the preterm neonate that will require invasive ventilation. | 2 years | 
| Anterior cerebral artery Doppler (measuring resistive index) and preprandial Superior mesenteric artery Doppler (measuring resistive index). | Anterior cerebral artery resistive index and preprandial Superior mesenteric artery resistive index measured for 70 preterm neonate on and off non invasive ventilation. 35 preterm placed on HHHFNC in comparison to 35 preterm placed on nCPAP. | 2 years | 
| Preprandial Superior mesenteric artery Doppler measuring superior mesenteric artery blood flow(mL/sec) | Preprandial Superior mesenteric artery blood flow(mL/sec) measured for 70 preterm neonate on and off non invasive ventilation. 35 preterm placed on HHHFNC in comparison to 35 preterm placed on nCPAP. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodynamic changes, High flow nasal cannula, Nasal continuous positive airway pressure, Respiratory distress syndrome, Prematurity