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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04238273
Enrollment
123
Registered
2020-01-23
Start date
2018-01-31
Completion date
2020-01-01
Last updated
2020-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

Hemodynamic changes, High flow nasal cannula, Nasal continuous positive airway pressure, Respiratory distress syndrome, Prematurity

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.

Interventions

Imaging studies to assess Hemodynamics of both groups on and off non invasive ventilation

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 4 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Echocardiography study for preterm neonates among the two study groups while on and off non invasive ventilation.2 yearsDone 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

MeasureTime frameDescription
Evaluate the efficacy of HHHFNC in comparison with nCPAP in preterm neonates.2 yearsThe 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.
Anterior cerebral artery Doppler (measuring resistive index) and preprandial Superior mesenteric artery Doppler (measuring resistive index).2 yearsAnterior 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.
Preprandial Superior mesenteric artery Doppler measuring superior mesenteric artery blood flow(mL/sec)2 yearsPreprandial 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026