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

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Respiratory Distress
• Intervention / Treatment: Device: High flow nasal cannula vs. Nasal continuous positive airway pressure

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).

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Magda Mahmoud Badawy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preterm neonates on HFNC; neonates extubated to HFNC (High flow nasal cannula)	Device: High flow nasal cannula vs. Nasal continuous positive airway pressure; High flow nasal cannula
Preterm neonates on NCPAP; neonates extubated to NCPAP ( nasal continuous positive airway pressure)	Device: High flow nasal cannula vs. Nasal continuous positive airway pressure; High flow nasal cannula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ramy Saleh Morsy

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): May 30, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: Post extubation HFNC vs. NCPAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No