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

Not Applicable

Recruiting

• Conditions: Preterm; Ventilator Lung; Newborn
• Interventions: Device: Nasal humidified heated high flow cannula (NHHHC); Device: Nasal intermittent positive pressure ventilation (NIPPV); Device: Nasal continuous positive airway pressure NCPAP; Device: lung ultrasound

• Registration Number: NCT06550219
• Lead Sponsor: Alexandria University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-04
• Study First Submitted QC: 2024-08-10
• Study First Posted: 2024-08-12
• Study Start: 2024-11-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-05-28
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nasal high flow cannula group	lung ultrasound	-
nasal intermittent positive pressure ventilation group	lung ultrasound	-
nasal continuous positive pressure ventilation group	lung ultrasound	-
nasal high flow cannula group	Nasal humidified heated high flow cannula (NHHHC)	-
nasal intermittent positive pressure ventilation group	Nasal intermittent positive pressure ventilation (NIPPV)	-
nasal continuous positive pressure ventilation group	Nasal continuous positive airway pressure NCPAP	-

Primary Outcome Measures

Name	Time	Method
Duration of non-Invasive ventilation (NIV)	First two weeks of life.	Describe the days of non-invasive ventilation , described in days number.

Secondary Outcome Measures

Name	Time	Method
Oxygen saturation index (OSI).	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.

Trial Locations

Locations (1)

Alexandria university, Elshattbi hospital; 🇪🇬 Alexandria, Egypt