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

Alexandria University30 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Preterm Ventilator Lung; Newborn

Interventions

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.

lung ultrasoundDEVICE

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).

Eligibility

Sex: ALLMin age: 1 HourMax age: 24 HoursHealthy volunteers:

Medical Language ↔ Plain English

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: 1. Obvious major congenital abnormalities. 2. Any of the baby intubated for resuscitation or for other reasons. 3. Neonates need invasive mechanical ventilation. 4. Pulmonary hemorrhage. 5. Severe cardiovascular instability. 6. Cardiopulmonary arrest needing prolonged resuscitation. 7. Birth asphyxia (one-minute Apgar score ≤ 3). 8. Major cardiac diseases (not including patent ductus arteriosus).

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.