Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06550219

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Preterm Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiratory Tract Diseases Urogenital Diseases Ventilator Lung; Newborn Ventilator-Induced Lung Injury

Age range

1 hour–24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria university, Elshattbi hospital

Alexandria, 0354, Egypt

Location status: Recruiting

Location contact

Marwa Mohamed Farag, phD

CONTACT

[email protected]

01288681788 ext. +2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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).

Primary outcomes

  1. 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

  1. Oxygen saturation index (OSI).

    Time frame: first one weeks of life.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marwa M Farag, PhD

CONTACT

[email protected]

01288681788

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2024
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.