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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04051762
Enrollment
100
Registered
2019-08-09
Start date
2017-06-01
Completion date
2018-07-30
Last updated
2019-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Respiratory Distress

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).

Interventions

DEVICEHigh flow nasal cannula vs. Nasal continuous positive airway pressure

High flow nasal cannula

Sponsors

Ramy Saleh Morsy
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
postextubation respiratory supportthrough study completion, an average of 1 yearcompare successful extubation of preterm (less than 34 weeks) into high flow nasal cannula versus continues positive airway pressure.

Secondary

MeasureTime frameDescription
postextubation respiratory support follow upthrough study completion, an average of 1 yearSecondary outcomes include the following: 1. Need for delayed reintubation (beyond 7 days) 2. Incidence of bronchopulmonary dysplasia. 3. Total number of days of hospital stay.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026