An observational study in Neonatal Respiratory Distress, sponsored by Ramy Saleh Morsy. Completed at 1 site in Egypt. Open to participants aged 1 Day to 28 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-09.
Sponsored by Ramy Saleh Morsy · Observational
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.
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).
1,179 studies on the registry are indexed under Respiratory Distress Syndrome, Newborn; 161 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 388 observational studies indexed under Respiratory Distress Syndrome, Newborn.
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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.
•Infants born at a gestational age of less than 34 weeks, receiving mechanical ventilation through an endotracheal tube.
Exclusion Criteria:
neonates extubated to HFNC (High flow nasal cannula)
Device: High flow nasal cannula vs. Nasal continuous positive airway pressure
neonates extubated to NCPAP ( nasal continuous positive airway pressure)
Device: High flow nasal cannula vs. Nasal continuous positive airway pressure
High flow nasal cannula
postextubation respiratory support
compare successful extubation of preterm (less than 34 weeks) into high flow nasal cannula versus continues positive airway pressure.
Time frame: through study completion, an average of 1 year
postextubation respiratory support follow up
Secondary 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.
Time frame: through study completion, an average of 1 year
Plan to share: No
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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome, Newborn→