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

Official title

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

Overview

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

Interventions

• Device Nasal humidified heated high flow cannula (NHHHC)
  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.
• Device Nasal intermittent positive pressure ventilation (NIPPV)
  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.
• Device Nasal continuous positive airway pressure NCPAP
  Patients in this arm will receive PEEP (positive end expiratory pressure ), stating from 5 mbar to reach maximally 8 mbar.
• Device lung ultrasound
  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).

Primary outcome measures

• Duration of non-Invasive ventilation (NIV) [Time frame: First two weeks of life.]

Secondary outcome measures (1)

• Oxygen saturation index (OSI). [Time frame: first one weeks of life.]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Alexandria university, Elshattbi hospital — Alexandria

Identifiers

NCT: NCT06550219 · 0108428

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗