Neonatal Respiratory DistressNCT04051762
A Comparative Study Between Postextubation of Preterm Infants Into High-Flow Nasal Cannulae V.S Nasal Continuous Positive Airway Pressure
An observational study of Neonatal Respiratory Distress, run by Ramy Saleh Morsy at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Respiratory Distress
- What is being tested?
- High flow nasal cannula vs. Nasal continuous positive airway pressure
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2017to 30 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- •Infants born at a gestational age of less than 34 weeks, receiving mechanical ventilation through an endotracheal tube.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Neonatal Respiratory Distress
- Being tested
- High flow nasal cannula vs. Nasal continuous positive airway pressure
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal cannula vs. Nasal continuous positive airway pressureDevice
High flow nasal cannula
| Study group | Role | What they receive |
|---|---|---|
| Preterm neonates on HFNC | neonates extubated to HFNC (High flow nasal cannula) Receives: Device: High flow nasal cannula vs. Nasal continuous positive airway pressure | |
| Preterm neonates on NCPAP | neonates extubated to NCPAP ( nasal continuous positive airway pressure) Receives: Device: High flow nasal cannula vs. Nasal continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
postextubation respiratory support
compare successful extubation of preterm (less than 34 weeks) into high flow nasal cannula versus continues positive airway pressure.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start1 Jun 2017
- Primary completion30 May 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramy Saleh Morsy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ramy Saleh Morsy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051762
- Sponsor's protocol ID
- Post extubation HFNC vs. NCPAP
- Status last verified
- Aug 2019
- First submitted
- 3 Jul 2019
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Postextubation of Preterm Infants Into High-Flow Nasal Cannulae V.S Nasal Continuous Positive Airway Pressure
- ClinicalTrials.gov ID
- NCT04051762
- Acronym / sponsor ID
- Post extubation HFNC vs. NCPAP
- Conditions
- Neonatal Respiratory Distress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ramy Saleh MorsyUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm neonates on HFNC | – | Device: High flow nasal cannula vs. Nasal continuous positive airway pressureneonates extubated to HFNC (High flow nasal cannula) |
| Preterm neonates on NCPAP | – | Device: High flow nasal cannula vs. Nasal continuous positive airway pressureneonates extubated to NCPAP ( nasal continuous positive airway pressure) |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- •Infants born at a gestational age of less than 34 weeks, receiving mechanical ventilation through an endotracheal tube.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow nasal cannula vs. Nasal continuous positive airway pressureHigh flow nasal cannula | Device | Preterm neonates on HFNC, Preterm neonates on NCPAP |
Primary outcome
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.
1 secondary outcome
postextubation respiratory support follow up
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Respiratory Distress, run by Ramy Saleh Morsy at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postextubation respiratory support (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.