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Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates

Primary Purpose

Ventilator Lung; Newborn, Hemodynamic Instability, Echocardiography

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
NHFOV
NCPAP
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventilator Lung; Newborn focused on measuring Premature infants, Echocardiography

Eligibility Criteria

1 Hour - 3 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group I

Group II

Arm Description

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

Nasal CPAP group (control group):

Outcomes

Primary Outcome Measures

Superior vena cava blood flow in ml/kg/min
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
Right ventricular output in ml /kg/min
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.
left ventricular output in ml/kg/min
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
peak systolic velocity in anterior cerebral artery in cm/sec
Trans-frontellar cranial sonography using Doppler study

Secondary Outcome Measures

Full Information

First Posted
January 21, 2023
Last Updated
August 18, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05706428
Brief Title
Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates
Official Title
Cardiorespiratory Effects of Nasal High Frequency Ventilation in Moderate and Late Preterm Infants With Respiratory Distress
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Lung; Newborn, Hemodynamic Instability, Echocardiography
Keywords
Premature infants, Echocardiography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Active Comparator
Arm Description
Nasal high-frequency ventilation (NHFV) group (case group):
Arm Title
Group II
Arm Type
Placebo Comparator
Arm Description
Nasal CPAP group (control group):
Intervention Type
Device
Intervention Name(s)
NHFOV
Intervention Description
The neonate patients with respiratory distress will have nasal high frequency ventilation as an initial mode of respiratory support.
Intervention Type
Device
Intervention Name(s)
NCPAP
Intervention Description
The neonate patients with respiratory distress will have nasal continuous positive airway pressure as an initial mode of respiratory support.
Primary Outcome Measure Information:
Title
Superior vena cava blood flow in ml/kg/min
Description
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
Time Frame
first 3 days of life
Title
Right ventricular output in ml /kg/min
Description
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.
Time Frame
first 3 days of life
Title
left ventricular output in ml/kg/min
Description
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
Time Frame
first 3 days of life
Title
peak systolic velocity in anterior cerebral artery in cm/sec
Description
Trans-frontellar cranial sonography using Doppler study
Time Frame
first 3 days of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nader Abdelminem Fasseh
Organizational Affiliation
Faculty of medicine, Alexandria University, Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Amen Hassan, MBChB
Organizational Affiliation
Faculty of medicine, Alexandria University, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.
City
Alexandria
ZIP/Postal Code
0356
Country
Egypt

12. IPD Sharing Statement

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Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates

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