Actively Recruiting

Phase Not Applicable
Age: 1Hour - 24Hours
All Genders
Healthy Volunteers
ID06550219

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

Led by Alexandria University · Updated on 2025-02-04

30

Participants Needed

1

Research Sites

22 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of three types of non-invasive ventilation methods—nasal intermittent positive pressure ventilation (NIPPV), nasal continuous positive airway pressure (NCPAP), and nasal high flow cannula (NHFC)—in preterm newborns born before 37 weeks of gestation who have moderate to severe respiratory distress. The study uses lung ultrasound (LUS) to assess ventilation outcomes such as the duration of non-invasive ventilation and other respiratory support needs during the first week of life. Participants receive one of the three ventilation methods: NIPPV using a device that adjusts pressure according to distress severity, NCPAP with positive end expiratory pressure starting from 5 mbar up to 8 mbar, or NHFC with humidified heated high flow starting at 2 L/min and increasing to 8 L/min based on oxygen needs. Lung ultrasound and other monitoring devices track respiratory function throughout the non-invasive ventilation period. During the study, newborns are closely monitored using lung ultrasound, measurements of heart rate, respiratory rate, oxygen saturation, blood gases, and other vital signs. Researchers will measure primary outcomes like the total duration of non-invasive ventilation during the first two weeks of life. Secondary outcomes include oxygen saturation index, need for intubation, surfactant use, bronchopulmonary dysplasia grading, and hospital stay length. The total participation period covers the initial two weeks of life with ongoing assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 1Hour - 24Hours
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm infants born before 37 weeks of gestational age
  • Admitted to the NICU with spontaneous breathing
  • Clinical signs of respiratory distress such as rapid breathing, nasal flaring, chest retractions, or grunting
  • Age less than 24 hours at enrollment
Not Eligible

You will not qualify if you...

  • Presence of major congenital abnormalities
  • Intubation for resuscitation or other reasons prior to enrollment
  • Need for invasive mechanical ventilation
  • Pulmonary hemorrhage
  • Severe cardiovascular instability
  • Cardiopulmonary arrest requiring prolonged resuscitation
  • Birth asphyxia with one-minute Apgar score of 3 or less
  • Major cardiac diseases excluding patent ductus arteriosus

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - First two weeks of life

Participants receive one of three types of nasal non-invasive ventilation devices to support breathing due to respiratory distress.

Continuous monitoring during ventilation period

Trial Site Locations

Total: 1 location

1

Alexandria university, Elshattbi hospital

Alexandria, Egypt, 0354

Actively Recruiting

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Research Team

M

Marwa M Farag, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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