Respiratory Distress Syndrome, NewbornNCT04238273
High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure for Respiratory Support of Preterm Neonates
An observational study of Respiratory Distress Syndrome, Newborn, run by Ain Shams University at 1 site in Egypt.
Trial summary
This work is designed to: 1. Evaluate the efficacy of HHHFNC in comparison with nCPAP in preterm neonates. 2. Investigate hemodynamic changes associated with HHHFNC in comparison to nCPAP in preterm neonates during periods of non-invasive respiratory support and after being off support. Read more about this study
- Who is it for?
- Ages Up to 4 weeks
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn
- What is being tested?
- Functional Echocardiography
- How many people
- 123 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Jan 2018to 1 Jan 2020
- 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 Up to 4 weeks
- All sexes
- No healthy volunteers
- Child
Study population: The study will be conducted on preterm neonates who required ventilatory support for respiratory distress syndrome (RDS) with previous invasive ventilation or not. The involved study group will be of matched gestational, postnatal age and sex.
Who may be able to join
- Infants are eligible if they meet the following criteria:
- Gestational age ≤ 35 weeks.
- Preterm neonates in need for non invasive ventilation whether they were on invasive ventilatory support before or not.
Who cannot join
- Preterm neonates with evidence of any of the following will be excluded:
- Major upper or lower airway anomalies.
- Significant congenital anomalies including cardiac, abdominal or respiratory.
- Hemodynamically significant patent ductus arteriosus (PDA): diagnosed if there is colour doppler echocardiographic evidence of left to right ductal shunt, ductal diameter >1.5mm/kg or left atrial/aortic root ratio >1.4
Trial locations and contacts
1 site in 1 country.
Egypt1 site
38 abbasia, next to nour mosque, Ain Shams University Hospital, Pediatrics department
Cairo, 11517
About this study
Official title: Hemodynamic Changes With Heated, Humidified High Flow Nasal Cannula (HHHFNC) Versus Nasal Continuous Positive Airway Pressure (nCPAP) for Respiratory Support of Preterm Neonates
This work is designed to:
- Evaluate the efficacy of HHHFNC in comparison with nCPAP in preterm neonates.
- Investigate hemodynamic changes associated with HHHFNC in comparison to nCPAP in preterm neonates during periods of non-invasive respiratory support and after being off support.
Read the detailed description
There is a preference of using noninvasive modes of ventilation for management of respiratory distress syndrome (RDS) in preterm infants and of weaning of ventilated neonates as soon as possible to non-invasive modes.
Yet, little is known about which non-invasive mode is better and the hemodynamic changes that occur to the infants secondary to these modes. The study provides an evaluation of the efficacy of heated, humidified high flow nasal cannula (HHHFNC) in comparison to nasal continuous positive airway pressure (nCPAP) in preterm infants. Secondary aim is to assess echographic, cerebral blood flow and mesenteric blood flow changes during HHHFNC versus nCPAP.
- Conditions
- Respiratory Distress Syndrome, Newborn
- Being tested
- Functional Echocardiography
- Keywords
- Hemodynamic changes, High flow nasal cannula, Nasal continuous positive airway pressure, Respiratory distress syndrome, Prematurity
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional EchocardiographyDiagnostic test
Also called Transcranial ultrasonography Doppler applied to the anterior cerebral artery, Assessment of pre-prandial superior mesenteric artery velocity and volume of blood flow with Doppler sonography
Imaging studies to assess Hemodynamics of both groups on and off non invasive ventilation
| Study group | Role | What they receive |
|---|---|---|
| HHHFNC | it included 63 preterm neonates on Heated, Humidified High Flow Nasal Cannula, of which 35 preterm underwent functional echocardiography, transcranial ultrasonography Doppler applied to the anterior cerebral artery and assessment of pre-prandial superior mesenteric artery velocity and volume of blood flow with Doppler sonography. All of which done while on non invasive ventilation and after weaning. Receives: Diagnostic Test: Functional Echocardiography | |
| NCPAP | it included 60 preterm neonates on Nasal Continuous Positive Airway Pressure, of which 35 preterm underwent functional echocardiography, transcranial ultrasonography Doppler applied to the anterior cerebral artery and assessment of pre-prandial superior mesenteric artery velocity and volume of blood flow with Doppler sonography. All of which done while on non invasive ventilation and after weaning. Receives: Diagnostic Test: Functional Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiography study for preterm neonates among the two study groups while on and off non invasive ventilation.
Done using Bedside functional echocardiography to record Superior vena caval flow (ml/kg/min), right ventricular output flow (ml/kg/min) and left ventricular output flow (ml/kg/min) for each preterm neonate in one of the two study groups (using either HHHFNC and nCPAP) on and off respiratory support.
Measured: 2 years
Secondary outcomes (3)
Evaluate the efficacy of HHHFNC in comparison with nCPAP in preterm neonates.
The percentage of success and failure among the HHHFNC and nCPAP groups , success defined as the preterm neonate that will not require invasive ventilation, while failure as the preterm neonate that will require invasive ventilation.
Measured: 2 years
Anterior cerebral artery Doppler (measuring resistive index) and preprandial Superior mesenteric artery Doppler (measuring resistive index).
Anterior cerebral artery resistive index and preprandial Superior mesenteric artery resistive index measured for 70 preterm neonate on and off non invasive ventilation. 35 preterm placed on HHHFNC in comparison to 35 preterm placed on nCPAP.
Measured: 2 years
Preprandial Superior mesenteric artery Doppler measuring superior mesenteric artery blood flow(mL/sec)
Preprandial Superior mesenteric artery blood flow(mL/sec) measured for 70 preterm neonate on and off non invasive ventilation. 35 preterm placed on HHHFNC in comparison to 35 preterm placed on nCPAP.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start31 Jan 2018
- Primary completion30 Nov 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, NewbornStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Ali El-Farrash, Ain Shams University
- Investigators
- Prof. Hisham Abdel Samie Awad, Study director, Ain Shams University,Medical school, Pediatrics department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238273
- Sponsor's protocol ID
- FMASU MD 386/2017
- Status last verified
- Jan 2020
- First submitted
- 9 Jan 2020
- Last updated
- 23 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
El-Farrash RA, Shinkar DM, Awad HA, Soliman NM, Al Sharabasy AH, Farid YA. Hemodynamic changes in preterm neonates with respiratory distress syndrome: high-flow nasal cannula versus nasal continuous positive airway pressure-a randomized controlled trial. Pediatr Res. 2026 Jun 4. doi: 10.1038/s41390-026-05127-9. Online ahead of print.
PubMed 42243499
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Changes With Heated, Humidified High Flow Nasal Cannula (HHHFNC) Versus Nasal Continuous Positive Airway Pressure (nCPAP) for Respiratory Support of Preterm Neonates
- ClinicalTrials.gov ID
- NCT04238273
- Acronym / sponsor ID
- FMASU MD 386/2017
- Conditions
- Respiratory Distress Syndrome, Newborn
- Keywords
- Hemodynamic changes, High flow nasal cannula, Nasal continuous positive airway pressure, Respiratory distress syndrome, Prematurity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 23 Jan 2020 (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.
This work is designed to:
- Evaluate the efficacy of HHHFNC in comparison with nCPAP in preterm neonates.
- Investigate hemodynamic changes associated with HHHFNC in comparison to nCPAP in preterm neonates during periods of non-invasive respiratory support and after being off support.
Detailed description
There is a preference of using noninvasive modes of ventilation for management of respiratory distress syndrome (RDS) in preterm infants and of weaning of ventilated neonates as soon as possible to non-invasive modes.
Yet, little is known about which non-invasive mode is better and the hemodynamic changes that occur to the infants secondary to these modes. The study provides an evaluation of the efficacy of heated, humidified high flow nasal cannula (HHHFNC) in comparison to nasal continuous positive airway pressure (nCPAP) in preterm infants. Secondary aim is to assess echographic, cerebral blood flow and mesenteric blood flow changes during HHHFNC versus nCPAP.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HHHFNC | – | Diagnostic Test: Functional Echocardiographyit included 63 preterm neonates on Heated, Humidified High Flow Nasal Cannula, of which 35 preterm underwent functional echocardiography, transcranial ultrasonography Doppler applied to the anterior cerebral artery and assessment of pre-prandial superior mesenteric artery velocity and volume of blood flow with Doppler sonography. All of which done while on non invasive ventilation and after weaning. |
| NCPAP | – | Diagnostic Test: Functional Echocardiographyit included 60 preterm neonates on Nasal Continuous Positive Airway Pressure, of which 35 preterm underwent functional echocardiography, transcranial ultrasonography Doppler applied to the anterior cerebral artery and assessment of pre-prandial superior mesenteric artery velocity and volume of blood flow with Doppler sonography. All of which done while on non invasive ventilation and after weaning. |
Who may qualify
- Ages
- Up to 4 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study will be conducted on preterm neonates who required ventilatory support for respiratory distress syndrome (RDS) with previous invasive ventilation or not. The involved study group will be of matched gestational, postnatal age and sex.
Key inclusion criteria (3 listed)
- Gestational age ≤ 35 weeks.
- Preterm neonates in need for non invasive ventilation whether they were on invasive ventilatory support before or not.
Key exclusion criteria (4 listed)
- Major upper or lower airway anomalies.
- Significant congenital anomalies including cardiac, abdominal or respiratory.
- Hemodynamically significant patent ductus arteriosus (PDA): diagnosed if there is colour doppler echocardiographic evidence of left to right ductal shunt, ductal diameter >1.5mm/kg or left atrial/aortic root ratio >1.4
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 |
|---|---|---|
| Functional EchocardiographyAlso: Transcranial ultrasonography Doppler applied to the anterior cerebral artery, Assessment of pre-prandial superior mesenteric artery velocity and volume of blood flow with Doppler sonographyImaging studies to assess Hemodynamics of both groups on and off non invasive ventilation | Diagnostic test | HHHFNC, NCPAP |
Primary outcome
Echocardiography study for preterm neonates among the two study groups while on and off non invasive ventilation.
Time frame: 2 years
Done using Bedside functional echocardiography to record Superior vena caval flow (ml/kg/min), right ventricular output flow (ml/kg/min) and left ventricular output flow (ml/kg/min) for each preterm neonate in one of the two study groups (using either HHHFNC and nCPAP) on and off respiratory support.
3 secondary outcomes
Evaluate the efficacy of HHHFNC in comparison with nCPAP in preterm neonates.
Time frame: 2 years
Anterior cerebral artery Doppler (measuring resistive index) and preprandial Superior mesenteric artery Doppler (measuring resistive index).
Time frame: 2 years
Preprandial Superior mesenteric artery Doppler measuring superior mesenteric artery blood flow(mL/sec)
Time frame: 2 years
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 23 Jan 2020.
- Derived from this study: PubMed 42243499El-Farrash RA, Shinkar DM, Awad HA, Soliman NM, Al Sharabasy AH, Farid YA. Hemodynamic changes in preterm neonates with respiratory distress syndrome: high-flow nasal cannula versus nasal continuous positive airway pressure-a randomized controlled trial. Pediatr Res. 2026 Jun 4. doi: 10.1038/s41390-026-05127-9. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
Prof. Hisham Abdel Samie Awad study director
Ain Shams University,Medical school, Pediatrics department
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 Respiratory Distress Syndrome, Newborn, run by Ain Shams University 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 3 inclusion and 4 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 23 Jan 2020. 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?
Echocardiography study for preterm neonates among the two study groups while on and off non invasive ventilation. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04238273, which also lists 1 linked publication.
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 23 Jan 2020.