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

NCT06550219 | Recruiting DMC

• 1 other identifier: 0108428
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Preterm; Ventilator Lung; Newborn

Keywords

preterm infants; non-invasive ventilation

Outcome Measures

Primary Outcomes (1)

• Duration of non-Invasive ventilation (NIV)

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

  First two weeks of life.

Secondary Outcomes (1)

• Oxygen saturation index (OSI).

  first one weeks of life.

Study Arms (3)

nasal intermittent positive pressure ventilation group

EXPERIMENTAL

Device: Nasal intermittent positive pressure ventilation (NIPPV); Device: lung ultrasound

nasal continuous positive pressure ventilation group

EXPERIMENTAL

Device: Nasal continuous positive airway pressure NCPAP; Device: lung ultrasound

nasal high flow cannula group

EXPERIMENTAL

Device: Nasal humidified heated high flow cannula (NHHHC); Device: lung ultrasound

Interventions

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 high flow cannula group

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 intermittent positive pressure ventilation group

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.

nasal continuous positive pressure ventilation group

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).

nasal continuous positive pressure ventilation group; nasal high flow cannula group; nasal intermittent positive pressure ventilation group

Eligibility Criteria

• Age: 1 Hour - 24 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria university, Elshattbi hospital

Alexandria, 0354, Egypt

RECRUITING

MeSH Terms

Conditions

Premature Birth; Bronchopulmonary Dysplasia

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Marwa M Farag, PhD

CONTACT

01288681788; d.marwa.farag@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: August 4, 2024
• First Posted: August 12, 2024
• Study Start: November 20, 2024
• Primary Completion: May 28, 2025
• Study Completion: November 1, 2025
• Last Updated: February 4, 2025

Record last verified: 2025-02

Locations

EG (1)