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

NCT ID: NCT07000071

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-01-30

Brief Summary

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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

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Conditions

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Neonates Respiratory Distress Non- Invasive Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nasal Continuous positive airway pressure (NCPAP)

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.

Group Type ACTIVE_COMPARATOR

NCPAP

Intervention Type DEVICE

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

Nasal intermittent pressure ventilation (NIPPV)

Neonates will be supported with NIPPV following extubation.

Group Type ACTIVE_COMPARATOR

NIPPV

Intervention Type DEVICE

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

Nasal high frequency ventilation (NHFOV)

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

Group Type ACTIVE_COMPARATOR

NHFOV

Intervention Type DEVICE

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

Interventions

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NCPAP

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

Intervention Type DEVICE

NIPPV

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

Intervention Type DEVICE

NHFOV

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Marwa Mohamed Farag

Assistant professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Marwa Mohamed Farag

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0201275

Identifier Type: -

Identifier Source: org_study_id