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Completed

NCT Number: NCT05706428

Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates

The aim of the present work is to study the cardio-respiratory effects of non-invasive ventilation (nasal high-frequency ventilation and nasal CPAP) as an initial therapy of respiratory distress in moderate and late preterm infants as regard:

I. Primary outcomes:

* Duration of the non- invasive respiratory support. * Need of invasive ventilation in the first 72 hours. * Short-term complications such as air leak syndromes, pulmonary hemorrhage, intraventricular hemorrhage, and nasal trauma.

II. Secondary outcomes:

* Need for surfactant administration. * Days on invasive mechanical ventilation. * Days on supplemental oxygen. * Duration of hospital stay. * Mortality rate. III. Hemodynamic changes during the period of non-invasive ventilation.

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Key information

Conditions

Ventilator Lung; Newborn Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Echocardiography Female Urogenital Diseases and Pregnancy Complications Hemodynamic Instability Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

1 hour–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.

Alexandria, 0356, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Moderate and late preterm infants born between 32+0 to 36+6 weeks gestation(according to WHO definitions of preterm birth) admitted to the neonatal intensive care unit with spontaneous breathing and clinical manifestations of RD (tachypnea, nasal flaring, intercostal and subcostal retraction and or grunting).

Exclusion criteria

  • Any baby intubated for resuscitation or for other reasons.
  • Obvious major congenital malformations or known complex congenital heart disease.
  • Pulmonary hemorrhage.
  • Cardiopulmonary arrest needing prolonged resuscitation.

Treatment and study plan

NHFOV

Device

The neonate patients with respiratory distress will have nasal high frequency ventilation as an initial mode of respiratory support.

NCPAP

Device

The neonate patients with respiratory distress will have nasal continuous positive airway pressure as an initial mode of respiratory support.

Primary outcomes

  1. Superior vena cava blood flow in ml/kg/min

    Time frame: first 3 days of life

    The SVC diameter will be visualized from a high parasternal long axis view. The maximum and minimum internal diameters will be then measured. ✓ The SVC flow velocity will be visualized from a low subcostal view and the pulsed Doppler recording will be made at the junction of the SVC and the right atrium. ✓ SVC flow will be calculated using the method described by Kluckow and Evans:(27) SVC flow (ml/kg/min) = [VTI (cm/beat) × 3.14 × (mean SVC diameter2

    /4) × heart rate (beat/min)] Body weight in kg 11

  2. Right ventricular output in ml /kg/min

    Time frame: first 3 days of life

    CSA (cm) (Cross sectional area of PV by long axis parasternal RV outflow view - 2D - immediately beneath pulmonary annulus

    • mid- systole - inner edge to inner edge) = π x (radius)2 ✓ VTI (cm) (Velocity Time Integral or Stroke Distance = Distance over which blood travels in once cardiac cycle → Long axis parasternal RV outflow view). ✓ SV (ml/beat) (Stroke Volume = CSA x VTI). ✓ Output (L/min.) COP = SV x HR.

  3. left ventricular output in ml/kg/min

    Time frame: first 3 days of life

    CSA (cm) (Cross sectional area of AV by long axis parasternal view - 2D - immediately beneath aortic annulus - mid- systole - inner edge to inner edge) = π x (radius) 2 . ✓ VTI (cm) (Velocity Time Integral or Stroke Distance = Distance over which blood travels in once cardiac cycle → Apical 5- chamber view). ✓ SV (ml/beat) (Stroke Volume = CSA x VTI). ✓ Output (L/min.) COP = SV x HR

  4. peak systolic velocity in anterior cerebral artery in cm/sec

    Time frame: first 3 days of life

    Trans-frontellar cranial sonography using Doppler study

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Cardiorespiratory Effects of Nasal High Frequency Ventilation in Moderate and Late Preterm Infants With Respiratory Distress

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2023
Registry last updated
Nov 7, 2023

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.

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