Respiratory Distress SyndromeNCT05849116
Effect of High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure
An observational study of Respiratory Distress Syndrome, run by Assiut University.
Trial summary
Respiratory distress syndrome (RDS) in preterm babies is caused by a deficiency of lung surfactant. The risk of RDS increases with decreasing gestational age, and is almost inevitable in babies born at less than 28 weeks gestation. Read more about this study
- Who is it for?
- Ages 30 to 37 weeks
- Conditions the study is for
- Respiratory Distress Syndrome
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Aug 2024
- 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 30 to 37 weeks
- All sexes
- Child
Study population: 100 preterm infants between 30 weeks and 37 weeks
Who may be able to join
- Preterm infants ≥30 weeks
- Preterm infants with birth weight >1000 gm
- Preterm infants diagnosed with respiratory distress syndrome.
Who cannot join
- Full term infants (>37 weeks)
- Preterm infants (<30 weeks \& less than 1000 gm)
- Neonates with respiratory distress other than respiratory distress syndrome.
- Neonates with neonatal sepsis.
- Neonates with congenital anomalies including congenital heart diseases.
- Neonates who need invasive MV immediately after birth.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure on Clinical Outcomes of Preterm Infants With Respiratory Distress Syndrome
Respiratory distress syndrome (RDS) in preterm babies is caused by a deficiency of lung surfactant. The risk of RDS increases with decreasing gestational age, and is almost inevitable in babies born at less than 28 weeks gestation. Without surfactant the lungs become stiff and the alveoli collapse at end-expiration, and untreated RDS is a major cause of morbidity and mortality in preterm infants
Read the detailed description
Respiratory distress syndrome (RDS) in preterm babies is caused by a deficiency of lung surfactant. The risk of RDS increases with decreasing gestational age, and is almost inevitable in babies born at less than 28 weeks gestation. Without surfactant the lungs become stiff and the alveoli collapse at end-expiration, and untreated RDS is a major cause of morbidity and mortality in preterm infants Respiratory distress is a common disease in infants, with an incidence rate of 7%, and preterm infants have higher incidences of respiratory distress. Clinical manifestations include apnea, cyanosis, wheezing-like breathing, nasal incontinence, feeding intolerance, shortness of breath or apnea, and inspiratory depression. The most common cause of respiratory distress in preterm infants is neonate respiratory distress syndrome (RDS) Surfactant is a naturally produced surface-active lipoprotein complex mixed with proteins, which reduces the surface tension at the alveolar liquid surface. Surfactant allows alveoli to stay open in expiration and substantially reduces the work of breathing. It also reduces shearing forces on immature alveolar membrane, preventing membrane rupture and protein leak into the alveolar space with resulting lung damage. RDS in preterm babies can be prevented by administration of exogenous animal derived surfactant therapy, and this substantially reduces mortality and respiratory morbidity for this population, including improved survival without bronchopulmonary dysplasia (BPD) at 28 days The use of noninvasive respiratory support, particularly nasal continuous positive airway pressure (nCPAP), has become a common strategy for early respiratory management of preterm infants. In recent years, heated, humidified high-flow nasal cannula (HHHFNC) has increased in popularity in high-resource countries as an alternative form of noninvasive respiratory support for newborn infants. In contrast to nCPAP, for which the rationale is essentially based on the provision of a continuous distending pressure, multiple mechanisms have been suggested to explain HHHFNC functioning, such as washout of the nasopharyngeal dead space, optimal gas conditioning, and provision of a variable distending pressure The HHHFNC approach has been applied in the neonatal intensive care unit (NICU) in a variety of clinical situations: weaning from nCPAP, preventing apnea of prematurity, following extubation, and as primary therapy for respiratory distress syndrome (RDS). Compared with nCPAP, HHHFNC offers ease of use, reduced risk of nasal injuries, better infant tolerance with improved feeding, and bonding HFNC works by providing inhaled gases at flows higher than the inspiratory demand flow. This leads to wash out of upper airways, reduces physiological dead space, and decreases nasopharyngeal airway resistance. It also provides variable positive end expiratory pressure and decreases work of breathing. But, as delivering HFNC requires a loose-fitting nasal prong, the pressure delivery is not reliable. The three important components of HFNC include a flow generator, an air-oxygen blender, and a heater-humidifier. HFNC has gained popularity because of the ease of use, lesser nasal trauma, and more comfort to the neonate Nasal CPAP is a method of delivering nasopharyngeal pressure to a spontaneously breathing neonate, where pressure is maintained throughout the respiratory cycle (both inspiration and expiration). Nasal CPAP works by decreasing airway resistance, increasing functional residual capacity, stabilizing chest wall, and splinting the airway (upper and lower). The preventive use of nasal CPAP (nCPAP) in preterm infants declines the need for mechanical ventilation and ultimately, reduces the rate of pneumothorax and mortality, especially accompanied with surfactant administration Invasive mechanical ventilation is widely used in neonatal intensive care units (NICUs). However, long-term invasive mechanical ventilation can lead to ventilator-related lung injuries, including pressure injuries, volume injuries, and ventilator pneumonia. In later stages, it may even lead to severe infection and bronchopulmonary dysplasia (BPD) The objective of the study was to evaluate the effect of high flow nasal cannula versus CPAP on the clinical outcomes of preterm infants with respiratory distress syndrome
- Conditions
- Respiratory Distress Syndrome
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High flow nasal cannula | preterms infants who are connected to high flow nasal cannula | |
| Continuous positive airway pressure | preterms who are connected to continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of invasive mechanical ventilation at the first 72 hours of life.
Regarding the following aspect:
The effect of high flow nasal cannula versus CPAP on the clinical outcomes of preterm infants with respiratory distress syndrome regarding the need for invasive mechanical ventilation at the first 72 hours of life.
Measured: first 72 hours of life
Time for weaning off from oxygen.
Regarding the following aspect:
The effect of high flow nasal cannula versus CPAP on the clinical outcomes of preterm infants with respiratory distress syndrome regarding the time for weaning off from oxygen.
Measured: Baseline
Duration of hospital stay.
Regarding the following aspect:
The effect of high flow nasal cannula versus CPAP on the clinical outcomes of preterm infants with respiratory distress syndrome regarding the duration of hospital stay.
Measured: Baseline
Rate of morbidity and mortality.
Regarding the following aspect:
The effect of high flow nasal cannula versus CPAP on the clinical outcomes of preterm infants with respiratory distress syndrome regarding the effect on morbidity and mortality.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noran Hasan Megally, Assiut University
- Investigators
- Gafar Ibrahim, Prof, Principal investigator, Assiut UniversitySafwat Moahmed, Assist prof, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849116
- Sponsor's protocol ID
- preterm infants with RDS
- Status last verified
- May 2023
- First submitted
- 24 Mar 2023
- Last updated
- 8 May 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure on Clinical Outcomes of Preterm Infants With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT05849116
- Acronym / sponsor ID
- preterm infants with RDS
- Conditions
- Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 8 May 2023 (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.
Respiratory distress syndrome (RDS) in preterm babies is caused by a deficiency of lung surfactant. The risk of RDS increases with decreasing gestational age, and is almost inevitable in babies born at less than 28 weeks gestation. Without surfactant the lungs become stiff and the alveoli collapse at end-expiration, and untreated RDS is a major cause of morbidity and mortality in preterm infants
Detailed description
Respiratory distress syndrome (RDS) in preterm babies is caused by a deficiency of lung surfactant. The risk of RDS increases with decreasing gestational age, and is almost inevitable in babies born at less than 28 weeks gestation. Without surfactant the lungs become stiff and the alveoli collapse at end-expiration, and untreated RDS is a major cause of morbidity and mortality in preterm infants Respiratory distress is a common disease in infants, with an incidence rate of 7%, and preterm infants have higher incidences of respiratory distress. Clinical manifestations include apnea, cyanosis, wheezing-like breathing, nasal incontinence, feeding intolerance, shortness of breath or apnea, and inspiratory depression. The most common cause of respiratory distress in preterm infants is neonate respiratory distress syndrome (RDS) Surfactant is a naturally produced surface-active lipoprotein complex mixed with proteins, which reduces the surface tension at the alveolar liquid surface. Surfactant allows alveoli to stay open in expiration and substantially reduces the work of breathing. It also reduces shearing forces on immature alveolar membrane, preventing membrane rupture and protein leak into the alveolar space with resulting lung damage. RDS in preterm babies can be prevented by administration of exogenous animal derived surfactant therapy, and this substantially reduces mortality and respiratory morbidity for this population, including improved survival without bronchopulmonary dysplasia (BPD) at 28 days The use of noninvasive respiratory support, particularly nasal continuous positive airway pressure (nCPAP), has become a common strategy for early respiratory management of preterm infants. In recent years, heated, humidified high-flow nasal cannula (HHHFNC) has increased in popularity in high-resource countries as an alternative form of noninvasive respiratory support for newborn infants. In contrast to nCPAP, for which the rationale is essentially based on the provision of a continuous distending pressure, multiple mechanisms have been suggested to explain HHHFNC functioning, such as washout of the nasopharyngeal dead space, optimal gas conditioning, and provision of a variable distending pressure The HHHFNC approach has been applied in the neonatal intensive care unit (NICU) in a variety of clinical situations: weaning from nCPAP, preventing apnea of prematurity, following extubation, and as primary therapy for respiratory distress syndrome (RDS). Compared with nCPAP, HHHFNC offers ease of use, reduced risk of nasal injuries, better infant tolerance with improved feeding, and bonding HFNC works by providing inhaled gases at flows higher than the inspiratory demand flow. This leads to wash out of upper airways, reduces physiological dead space, and decreases nasopharyngeal airway resistance. It also provides variable positive end expiratory pressure and decreases work of breathing. But, as delivering HFNC requires a loose-fitting nasal prong, the pressure delivery is not reliable. The three important components of HFNC include a flow generator, an air-oxygen blender, and a heater-humidifier. HFNC has gained popularity because of the ease of use, lesser nasal trauma, and more comfort to the neonate Nasal CPAP is a method of delivering nasopharyngeal pressure to a spontaneously breathing neonate, where pressure is maintained throughout the respiratory cycle (both inspiration and expiration). Nasal CPAP works by decreasing airway resistance, increasing functional residual capacity, stabilizing chest wall, and splinting the airway (upper and lower). The preventive use of nasal CPAP (nCPAP) in preterm infants declines the need for mechanical ventilation and ultimately, reduces the rate of pneumothorax and mortality, especially accompanied with surfactant administration Invasive mechanical ventilation is widely used in neonatal intensive care units (NICUs). However, long-term invasive mechanical ventilation can lead to ventilator-related lung injuries, including pressure injuries, volume injuries, and ventilator pneumonia. In later stages, it may even lead to severe infection and bronchopulmonary dysplasia (BPD) The objective of the study was to evaluate the effect of high flow nasal cannula versus CPAP on the clinical outcomes of preterm infants with respiratory distress syndrome
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow nasal cannula | – | –preterms infants who are connected to high flow nasal cannula |
| Continuous positive airway pressure | – | –preterms who are connected to continuous positive airway pressure |
Who may qualify
- Ages
- 30 to 37 weeks
- Sex
- All
- Age groups
- Child
- Study population
- 100 preterm infants between 30 weeks and 37 weeks
Key inclusion criteria (3 listed)
- Preterm infants ≥30 weeks
- Preterm infants with birth weight >1000 gm
- Preterm infants diagnosed with respiratory distress syndrome.
Key exclusion criteria (6 listed)
- Full term infants (>37 weeks)
- Preterm infants (<30 weeks \& less than 1000 gm)
- Neonates with respiratory distress other than respiratory distress syndrome.
- Neonates with neonatal sepsis.
- Neonates with congenital anomalies including congenital heart diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The rate of invasive mechanical ventilation at the first 72 hours of life.
Time frame: first 72 hours of life
Regarding the following aspect: The effect of high flow nasal cannula versus CPAP on the clinical outcomes of preterm infants with respiratory distress syndrome regarding the need for invasive mechanical ventilation at the first 72 hours of life.
Time for weaning off from oxygen.
Time frame: Baseline
Regarding the following aspect: The effect of high flow nasal cannula versus CPAP on the clinical outcomes of preterm infants with respiratory distress syndrome regarding the time for weaning off from oxygen.
Duration of hospital stay.
Time frame: Baseline
Regarding the following aspect: The effect of high flow nasal cannula versus CPAP on the clinical outcomes of preterm infants with respiratory distress syndrome regarding the duration of hospital stay.
Rate of morbidity and mortality.
Time frame: Baseline
Regarding the following aspect: The effect of high flow nasal cannula versus CPAP on the clinical outcomes of preterm infants with respiratory distress syndrome regarding the effect on morbidity and mortality.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
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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.
Gafar Ibrahim, Prof principal investigator
Assiut University
Safwat Moahmed, Assist prof principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, run by Assiut University.
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 6 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: status not confirmed, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noran Hasan (01067919682, noranhasanmegally2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of invasive mechanical ventilation at the first 72 hours of life. (time frame: first 72 hours of life). The study lists 4 primary outcomes in all. 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 8 May 2023.