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

Completed

• Conditions: Respiratory Distress Syndrome, Newborn

• Registration Number: NCT04238273
• Lead Sponsor: Ain Shams University

Brief Summary

This work is designed to:

1. Evaluate the efficacy of HHHFNC in comparison with nCPAP in preterm neonates.

2. 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

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.

Study Timeline

• Study Start: 2018-01-31
• Primary Completion: 2019-11-30
• Status Verified: 2020-01
• Study Completion: 2020-01-01
• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-19
• Last Update Submitted: 2020-01-19
• Study First Posted: 2020-01-23
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

Infants are eligible if they meet the following criteria:

1. Gestational age ≤ 35 weeks.
2. 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:

1. Major upper or lower airway anomalies.
2. Significant congenital anomalies including cardiac, abdominal or respiratory.
3. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Echocardiography study for preterm neonates among the two study groups while on and off non invasive ventilation.	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Anterior cerebral artery Doppler (measuring resistive index) and preprandial Superior mesenteric artery Doppler (measuring resistive index).	2 years	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.
Evaluate the efficacy of HHHFNC in comparison with nCPAP in preterm neonates.	2 years	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.
Preprandial Superior mesenteric artery Doppler measuring superior mesenteric artery blood flow(mL/sec)	2 years	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.

Trial Locations

Locations (1)

38 abbasia, next to nour mosque, Ain Shams University Hospital, Pediatrics department; 🇪🇬 Cairo, Egypt