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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome, Newborn
• Intervention / Treatment: Diagnostic test: Functional Echocardiography

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 Type: Observational
• Enrollment (Actual): 123

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11517
    • 38 abbasia, next to nour mosque, Ain Shams University Hospital, Pediatrics department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study will be conducted on preterm neonates who required ventilatory support for respiratory distress syndrome (RDS) with previous invasive ventilation or not. The involved study group will be of matched gestational, postnatal age and sex.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HHHFNC; 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; Imaging studies to assess Hemodynamics of both groups on and off non invasive ventilation; Other Names: Transcranial ultrasonography Doppler applied to the anterior cerebral artery; Assessment of pre-prandial superior mesenteric artery velocity and volume of blood flow with Doppler sonography
NCPAP; 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; Imaging studies to assess Hemodynamics of both groups on and off non invasive ventilation; Other Names: Transcranial ultrasonography Doppler applied to the anterior cerebral artery; Assessment of pre-prandial superior mesenteric artery velocity and volume of blood flow with Doppler sonography

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Prof. Hisham Abdel Samie Awad, Ain Shams University,Medical school, Pediatrics department

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2018
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 19, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 19, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Prematurity; High flow nasal cannula; Respiratory distress syndrome; Hemodynamic changes; Nasal continuous positive airway pressure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: FMASU MD 386/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No