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

NCT07000071 | Completed

• 1 other identifier: 0201275
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonates; Respiratory Distress; Non- Invasive Ventilation

Outcome Measures

Primary Outcomes (1)

• Failure rate

  need for reintubation and invasive mechanical ventilation

  72 hours after weaning

Secondary Outcomes (1)

• duration of non-invasive ventilation

  first 72 hours after weaning from mechanical ventillation

Study Arms (3)

Nasal Continuous positive airway pressure (NCPAP)

ACTIVE COMPARATOR

apply continuous positive airway pressure using nasopharyngeal interface. positive end expiratory pressure (PEEP ) used 5-7 cm H2O. Neonates will be supported with NCPAP following extubation.

Device: NCPAP

Nasal intermittent pressure ventilation (NIPPV)

ACTIVE COMPARATOR

Neonates will be supported with NIPPV following extubation.

Device: NIPPV

Nasal high frequency ventilation (NHFOV)

ACTIVE COMPARATOR

Neonates will be supported with NHFOV following extubation. stating mean airway pressure 8 and can reach upto 15 cm H2O Delta pressure used is 20 Frequency 10 HZ

Device: NHFOV

Interventions

NCPAP DEVICE

Apply nasal continuous positive airway pressure in intubated patients with respiratory distress at time of weaning

Nasal Continuous positive airway pressure (NCPAP)

NIPPV DEVICE

Apply nasal intermittent positive pressure ventilation in intubated patients with respiratory distress at time of weaning

Nasal intermittent pressure ventilation (NIPPV)

NHFOV DEVICE

Apply nasal high frequency ventilation in intubated patients with respiratory distress at time of weaning

Nasal high frequency ventilation (NHFOV)

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Marwa Mohamed Farag

Alexandria, 0325, Egypt

Location

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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 of Pediatrics

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: May 31, 2025
• Study Start: July 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: January 30, 2022
• Last Updated: May 31, 2025

Record last verified: 2025-01

Locations

EG (1)