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

NCT07000071 — Not applicable, Completed, 40 participants, Alexandria University

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Registry	NCT07000071
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	40 (Actual)
Sponsor	Alexandria University (Other)
Conditions	Neonates, Respiratory Distress, Non- Invasive Ventilation
Interventions	NCPAP, NIPPV, NHFOV (Device)
Dates	start 2021-07-01, primary completion 2021-12-30, completion 2022-01-30, first posted 2025-05-31, last updated 2025-05-31
Locations	1 site in Egypt

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Nasal Continuous positive airway pressure (NCPAP)	Active comparator	Device: 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.
Nasal intermittent pressure ventilation (NIPPV)	Active comparator	Device: NIPPV	Neonates will be supported with NIPPV following extubation.
Nasal high frequency ventilation (NHFOV)	Active comparator	Device: 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

NCPAP (Device): Apply nasal continuous positive airway pressure in intubated patients with respiratory distress at time of weaning
NIPPV (Device): Apply nasal intermittent positive pressure ventilation in intubated patients with respiratory distress at time of weaning
NHFOV (Device): Apply nasal high frequency ventilation in intubated patients with respiratory distress at time of weaning

+Outcome measures

Primary outcomes

Failure rate [72 hours after weaning]: need for reintubation and invasive mechanical ventilation

Secondary outcomes

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

+Eligibility

Sex: All, ages: 1 Day to 14 Days, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Marwa Mohamed Farag	Alexandria	Egypt