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Completed

NCT Number: NCT04051762

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.

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Key information

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Magda Mahmoud Badawy

Cairo, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High flow nasal cannula vs. Nasal continuous positive airway pressure

Device

High flow nasal cannula

Primary outcomes

  1. postextubation respiratory support

    Time frame: through study completion, an average of 1 year

    compare successful extubation of preterm (less than 34 weeks) into high flow nasal cannula versus continues positive airway pressure.

Secondary outcomes

  1. postextubation respiratory support follow up

    Time frame: through study completion, an average of 1 year

    Secondary outcomes include the following:

    • Need for delayed reintubation (beyond 7 days)
    • Incidence of bronchopulmonary dysplasia.
    • Total number of days of hospital stay.

Sponsors and collaborators

Lead sponsor

Ramy Saleh Morsy

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 9, 2019
Registry last updated
Aug 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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