Non-invasive Secondary Respiratory Support in Late Preterm and Term Infants

Not Applicable

Completed

• Conditions: Neonates; Respiratory Distress; Non- Invasive Ventilation

• Registration Number: NCT07000071
• Lead Sponsor: Alexandria University

Brief Summary

The aim of the present work is to compare between various modes of non-invasive respiratory support (including NCPAP, NIPPV, and NHFOV) as secondary respiratory support modes in late preterm and term neonates as regards the need for reintubation. Additionally, the study aims at comparing between the three modes concerning the associated morbidity and mortality.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Primary Completion: 2021-12-30
• Study Completion: 2022-01-30
• Status Verified: 2025-01
• Study First Submitted: 2025-05-23
• Study First Submitted QC: 2025-05-23
• Last Update Submitted: 2025-05-23
• Study First Posted: 2025-05-31
• Last Update Posted: 2025-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• The gestational age (GA) is between 34 and 41 weeks.
• Extubation from invasive mechanical ventilation initiated due to RD, irrespective to the cause of RD.
• Respiratory distress is assessed based on clinical manifestations (tachypnea, nasal flaring, intercostal retractions, diminished air entry, and or grunting)

Exclusion Criteria

• Major congenital anomalies.
• Major cardiac diseases.
• Presence of cardiovascular instability (sepsis, severe dehydration, severe anemia).
• Neurologically insulted neonates who are unable to take adequate spontaneous breathing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Failure rate	72 hours after weaning	need for reintubation and invasive mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
duration of non-invasive ventilation	first 72 hours after weaning from mechanical ventillation	duration of noninvasive ventilation till patients become weaned to free flow oxygen

Trial Locations

Locations (1)

Marwa Mohamed Farag; 🇪🇬 Alexandria, Egypt