Skip to main content
OpenTrials
Completed

NCT Number: NCT04238273

High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Distress Syndrome, Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Urogenital Diseases

Age range

Up to 4 week

Sex eligibility

All sexes

Study type

Observational

Primary location

38 abbasia, next to nour mosque, Ain Shams University Hospital, Pediatrics department

Cairo, 11517, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional Echocardiography

Diagnostic Test

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

Primary outcomes

  1. Echocardiography study for preterm neonates among the two study groups while on and off non invasive ventilation.

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Anterior cerebral artery Doppler (measuring resistive index) and preprandial Superior mesenteric artery Doppler (measuring resistive index).

    Time frame: 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.

  3. Preprandial Superior mesenteric artery Doppler measuring superior mesenteric artery blood flow(mL/sec)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 23, 2020
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.