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

NCT07869719 | Not Yet Recruiting

• 1 other identifier: nCPAP-HFNC-RDS-Assiut-2026
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Respiratory Distress Syndrome; Premature Birth

Keywords

nCPAP; High-flow nasal cannula; Respiratory distress syndrome; NICU; Assiut; Preterm infants

Outcome Measures

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.

  At 72 hours

Secondary Outcomes (5)

• Need for mechanical ventilation

  At 72 hours

• Need for surfactant therapy

  At 72 hours

• Duration of respiratory support

  At 28 days

• Incidence of nasal trauma

  At 28 days

• Incidence of pneumothorax

  At 28 days

Study Arms (2)

Nasal Continuous Positive Airway Pressure

EXPERIMENTAL

Preterm infants will receive nasal continuous positive airway pressure through an appropriate neonatal interface.

Device: Non-invasive respiratory support

High-Flow Nasal Cannula

ACTIVE COMPARATOR

Preterm infants will receive heated and humidified high-flow nasal cannula therapy.

Device: Non-invasive respiratory support

Interventions

Non-invasive respiratory support DEVICE

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

High-Flow Nasal Cannula; Nasal Continuous Positive Airway Pressure

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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
• Written informed consent from parent or legal guardian

You may not qualify if:

• \- Infants requiring immediate endotracheal intubation and mechanical ventilation
• Major congenital anomalies affecting the respiratory or cardiovascular systems
• Congenital diaphragmatic hernia
• Significant congenital heart disease
• Severe perinatal asphyxia requiring prolonged resuscitation
• Severe hemodynamic instability
• Prolonged mechanical ventilation before enrollment

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Respiratory Distress Syndrome; Premature Birth

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Hekma S Farghaly, prof

  Pediatrics Department, Assiut University Hospitals

  STUDY CHAIR

Central Study Contacts

Yara S Mahmoud, Resident

CONTACT

+20 11 53798964; Yara.17298705@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Pediatrics

Study Record Dates

• First Submitted: October 6, 2026
• First Posted: October 9, 2026
• Study Start: October 10, 2026
• Primary Completion (Estimated): October 10, 2027
• Study Completion (Estimated): February 25, 2028
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share