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Clinical Trials/NCT06550219
NCT06550219RecruitingNot Applicable

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

Alexandria University2 sites in 1 country30 target enrollmentStarted: November 20, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
30
Locations
2
Primary Endpoint
Duration of non-Invasive ventilation (NIV)

Study 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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
1 Hour to 24 Hours (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marwa Mohamed Farag

Assistant professor

Alexandria University

Study Sites (2)

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