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

Alexandria University

Status: Completed

Conditions: Neonates; Non- Invasive Ventilation; Respiratory Distress

Treatments: Device: NCPAP; Device: NIPPV; Device: NHFOV

Study type: Interventional

Funder types: Other

Identifiers

NCT07000071

0201275

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 1 to 14 days old

Volunteers: 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Nasal Continuous positive airway pressure (NCPAP)

Active Comparator group

Description:

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.

Treatment:

Device: NCPAP

Nasal intermittent pressure ventilation (NIPPV)

Active Comparator group

Description:

Neonates will be supported with NIPPV following extubation.

Treatment:

Device: NIPPV

Nasal high frequency ventilation (NHFOV)

Active Comparator group

Description:

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

Treatment:

Device: NHFOV