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

Respiratory Distress Syndrome, Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04238273
• Other study ID #: FMASU MD 386/2017
• Status: Completed
• Start date: January 31, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: January 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: January 1, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Diagnostic Test:
• Functional Echocardiography
Imaging studies to assess Hemodynamics of both groups on and off non invasive ventilation

Locations

Country	Name	City	State
Egypt	38 abbasia, next to nour mosque, Ain Shams University Hospital, Pediatrics department	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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