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

ConditionsPreterm Ventilator Lung; Newborn

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age1-24

SponsorAlexandria University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Obvious major congenital abnormalities.

Any of the baby intubated for resuscitation or for other reasons.

Neonates need invasive mechanical ventilation.

Pulmonary hemorrhage.

Trial design

Design model

Parallel

Treatments tested in this trial

Nasal humidified heated high flow cannula (NHHHC)
Device
Patients in this arm will receive humidified heated high flow using Vapotherm device, USA. Stating with 2 L/min flow and increase gradually till 8L/minute, guided by oxygen requirements.
Nasal intermittent positive pressure ventilation (NIPPV)
Device
Patients in this arm will receive both PEEP (positive end expiratory pressure ) and PIP (peak inspiratory pressure) using SLE 5000/6000 device, UK . Pressures will be adjusted according to severity of respiratory distress.
Nasal continuous positive airway pressure NCPAP
Device
Patients in this arm will receive PEEP (positive end expiratory pressure ), stating from 5 mbar to reach maximally 8 mbar.
lung ultrasound
Device
Lung ultrasound (LUS) machine is a mobile device (Philips HDll XE, USA) with s8-3 probe with a frequency range of 8-3 MHz will be used as ultrasound machine. Throughout the period of non-invasive respiratory support Patient will be monitored by: LUS,Heart rate, Respiratory rate, Mean arterial pressure, Oxygen saturation index, Oxygen index, PaO2, blood gases and Fractional inspired oxygen (Fio2).

Treatment groups

30 Participants

are divided into 3 treatment groups

Group A: nasal intermittent positive pressure ventilation groupExperimental treatment 2 interventions

Group B: nasal continuous positive pressure ventilation groupExperimental treatment 2 interventions

Group C: nasal high flow cannula groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Duration of non-Invasive ventilation (NIV)

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

Time frame

First two weeks of life.

Secondary outcomes

Oxygen saturation index (OSI).

Mean airway pressure (MAP)X Fraction of inspired oxygen (FIO2) X SPO2 ( oxygen saturation) The score of OSI is recorded twice per day for first seven days.

Time frame

first one weeks of life.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexandria University

Lead sponsor

Source ClinicalTrials.gov

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