A Comparative Study Between Postextubation of Preterm Infants Into High-Flow Nasal Cannulae V.S Nasal Continuous Positive Airway Pressure

Ramy Saleh Morsy

Status: Completed

Conditions: Neonatal Respiratory Distress

Treatments: Device: High flow nasal cannula vs. Nasal continuous positive airway pressure

Study type: Observational

Funder types: Other

Identifiers

NCT04051762

Post extubation HFNC vs. NCPAP

Details and patient eligibility

About

The investigators hypothesize that there is a growing trend of the feasibility of HFNC as an alternative to other forms of non-invasive ventilation mechanism to provide continuous distending pressure to preterm infants. However, there remains uncertainty about the efficacy and safety of HFNC in this population.

Full description

Our primary outcome is to determine whether postextubation respiratory support via heated humidified high-flow nasal cannula results in a greater proportion of infants younger than 34 weeks gestation being successfully extubated after a period of endotracheal positive pressure ventilation compared with conventional (NCPAP).

The following study will be conducted in the neonatal intensive care unit (NICU) of Gynecology and Obstetric department of Kasr El Aini hospital and neonatal intensive care unit of Military Hospital throughout a time interval of at least 6 months for a minimum of 100 preterm infants.

Infants will be eligible for the study if they born at less than 34 weeks' gestation, required endotracheal intubation and positive pressure ventilation, and considered ready for extubation by the clinical team.

The investigators will assign extubation of preterm ventilated infants (50 preterm infant) in NICU of Military Hospital into HHFNC and extubation of preterm ventilated infants (50 preterm infant) in (NICU) of Gynecology and Obstetric department of Kasr El Aini hospital into NCPAP (50 preterm infant).

Enrollment: 100 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

•Infants born at a gestational age of less than 34 weeks, receiving mechanical ventilation through an endotracheal tube.

Exclusion criteria

• Full term neonates or large for gestational age.
• Preterm neonates not supported primarily by invasive ventilation.
• Infants with suspected upper airway obstruction, congenital airway malformations or major cardiopulmonary malformations.

Trial design

100 participants in 2 patient groups

Preterm neonates on HFNC

Description:

neonates extubated to HFNC (High flow nasal cannula)

Treatment:

Device: High flow nasal cannula vs. Nasal continuous positive airway pressure

Preterm neonates on NCPAP

Description:

neonates extubated to NCPAP ( nasal continuous positive airway pressure)

Treatment:

Device: High flow nasal cannula vs. Nasal continuous positive airway pressure