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Clinical Trials/NCT06550219
NCT06550219
Recruiting
Not Applicable

Evaluation of Nasal Non Invasive Ventilation Modalities in Management of Neonates With Respiratory Distress Using Lung Ultrasound

Alexandria University1 site in 1 country30 target enrollmentNovember 20, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm
Sponsor
Alexandria University
Enrollment
30
Locations
1
Primary Endpoint
Duration of non-Invasive ventilation (NIV)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

This study aims to evaluate the effect of non-invasive ventilation (nIPPV)

, (nCPAP), and nasal high flow cannula (NHFC) as a primary mode of ventilation in preterm neonates <37 gestational week with moderate to severe RD using LUS as regard: I. Primary outcomes: Duration of non-Invasive ventilation. II. Secondary outcomes: Evaluation LUS over the 1 st 7 days of life or weaning from ventilation. Need for intubation and invasive ventilation. Duration of respiratory support. Need for surfactant. Oxygen saturation index and oxygen index. Broncho-pulmonary dysplasia; grade. Duration of hospital stay

Registry
clinicaltrials.gov
Start Date
November 20, 2024
End Date
November 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marwa Mohamed Farag

Assistant professor

Alexandria University

Eligibility Criteria

Inclusion Criteria

  • Preterm \<37 wk. gestational age admitted to the NICU with spontaneous breathing and clinical manifestations of RD (tachypnea, nasal flaring, intercostal and subcostal retraction and or grunting).

Exclusion Criteria

  • Obvious major congenital abnormalities.
  • Any of the baby intubated for resuscitation or for other reasons.
  • Neonates need invasive mechanical ventilation.
  • Pulmonary hemorrhage.
  • Severe cardiovascular instability.
  • Cardiopulmonary arrest needing prolonged resuscitation.
  • Birth asphyxia (one-minute Apgar score ≤ 3).
  • Major cardiac diseases (not including patent ductus arteriosus).

Outcomes

Primary Outcomes

Duration of non-Invasive ventilation (NIV)

Time Frame: First two weeks of life.

Describe the days of non-invasive ventilation , described in days number.

Secondary Outcomes

  • Oxygen saturation index (OSI).(first one weeks of life.)

Study Sites (1)

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