Health TrialsbyHealthPanel

nCPAP Versus High-Flow Nasal Cannula in Preterm Infants With RDS

ConditionsRespiratory Distress SyndromePremature Birth
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 28
SponsorAssiut University

About this trial

This randomized controlled trial aims to compare the efficacy and safety of nasal continuous positive airway pressure versus high-flow nasal cannula as initial non-invasive respiratory support in preterm infants with respiratory distress syndrome.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- Preterm infants with gestational age 28 to 36 weeks and 6 days

Clinical diagnosis of respiratory distress syndrome

Spontaneous breathing without immediate need for invasive mechanical ventilation

Requirement for non-invasive respiratory support

Disqualifiers

- Infants requiring immediate endotracheal intubation and mechanical ventilation

Major congenital anomalies affecting the respiratory or cardiovascular systems

Congenital diaphragmatic hernia

Significant congenital heart disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Non-invasive respiratory support

    Device

    Non-invasive respiratory support using either nCPAP or high-flow nasal cannula according to group allocation.

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: Nasal Continuous Positive Airway PressureExperimental treatment 1 intervention
Group B: High-Flow Nasal CannulaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Treatment failure within 72 hours

Number of infants meeting predefined criteria for treatment failure of the assigned non-invasive respiratory support modality within the first 72 hours.

Time frame
At 72 hours

Secondary outcomes

1

Need for mechanical ventilation

Number of infants requiring endotracheal intubation and mechanical ventilation.

Time frame
At 72 hours
2

Need for surfactant therapy

Number of infants requiring surfactant administration.

Time frame
At 72 hours
3

Duration of respiratory support

Mean duration of non-invasive respiratory support in days.

Time frame
At 28 days
4

Incidence of nasal trauma

Number of infants who develop nasal trauma related to the respiratory support interface.

Time frame
At 28 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: