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Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates

Sponsor
Alexandria University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05706428
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
19.6
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: NHFOV
  • Device: NCPAP
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Cardiorespiratory Effects of Nasal High Frequency Ventilation in Moderate and Late Preterm Infants With Respiratory Distress
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Jul 20, 2023
Anticipated Study Completion Date :
Aug 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group I

Nasal high-frequency ventilation (NHFV) group (case group):

Device: NHFOV
The neonate patients with respiratory distress will have nasal high frequency ventilation as an initial mode of respiratory support.
Placebo Comparator: Group II

Nasal CPAP group (control group):

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

Outcome Measures

Primary Outcome Measures

  1. Superior vena cava blood flow in ml/kg/min [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 [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 [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 [first 3 days of life]

    Trans-frontellar cranial sonography using Doppler study

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Hour to 3 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital. Alexandria Egypt 0356

Sponsors and Collaborators

  • Alexandria University

Investigators

  • Study Director: Nader Abdelminem Fasseh, Faculty of medicine, Alexandria University, Egypt
  • Principal Investigator: Mohamed Amen Hassan, MBChB, Faculty of medicine, Alexandria University, Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marwa Mohamed Farag, Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine, Alexandria University
ClinicalTrials.gov Identifier:
NCT05706428
Other Study ID Numbers:
  • 0201417
First Posted:
Jan 31, 2023
Last Update Posted:
Feb 6, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marwa Mohamed Farag, Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine, Alexandria University
Premature infants
Echocardiography
Additional relevant MeSH terms:
Bronchopulmonary Dysplasia

Study Results

No Results Posted as of Feb 6, 2023