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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

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 groups in NCT05849116
Study groupRoleWhat they receive
High flow nasal cannulapreterms infants who are connected to high flow nasal cannula
Continuous positive airway pressurepreterms 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.

  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted8 May 2023
  2. Study start1 Jun 2023 (estimated)
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Aug 2024 (estimated)

Resources

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)
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

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.

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