Clinical trial NCT04051762: A Comparative Study Between Postextubation of Preterm Infants Into High-Flow Nasal Cannulae V.S Nasal Continuous Positive Airway Pressure
Official title: A Comparative Study Between Postextubation of Preterm Infants Into High-Flow Nasal Cannulae V.S Nasal Continuous Positive Airway Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Respiratory Distress
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: postextubation respiratory support
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: postextubation respiratory support follow up
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Magda Mahmoud Badawy
Study officials:
References: