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

Neonatal Respiratory Distress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04051762
• Other study ID #: Post extubation HFNC vs. NCPAP
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: August 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Neonatal Respiratory Distress
• Respiratory Distress Syndrome, Newborn

Intervention

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

Locations

Country	Name	City	State
Egypt	Magda Mahmoud Badawy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ramy Saleh Morsy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postextubation respiratory support	compare successful extubation of preterm (less than 34 weeks) into high flow nasal cannula versus continues positive airway pressure.	through study completion, an average of 1 year
Secondary	postextubation respiratory support follow up	Secondary outcomes include the following: Need for delayed reintubation (beyond 7 days); Incidence of bronchopulmonary dysplasia.; Total number of days of hospital stay.	through study completion, an average of 1 year