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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07000071

Enrollment

Registered

2025-05-31

Start date

2021-07-01

Completion date

2022-01-30

Last updated

2025-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonates, Non- Invasive Ventilation, Respiratory Distress

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.

Interventions

DEVICENCPAP

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

DEVICENIPPV

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

DEVICENHFOV

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 14 Days

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Failure rate	72 hours after weaning	need for reintubation and invasive mechanical ventilation

Secondary

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026