Comparison of X-Breathe HFNC Neo™ high-flow nasal cannula versus standard continuous positive airway pressure in late preterm neonates with respiratory distress

Performance of X-Breathe HFNC Neo™ oxygenation in late preterm neonates with respiratory distress

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16740838

Enrollment

Registered

2025-04-23

Start date

2022-10-01

Completion date

Unknown

Last updated

2025-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory distress Respiratory

Interventions

The interventions in this study include the XBreathe Neo™ High-Flow Nasal Cannula (HFNC) and the standard Continuous Positive Airway Pressure (CPAP) device routinely used at Bandung Kiwari General Hos

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Neonates with a gestational age of more than 28 weeks 2. Birth weight exceeding 1500 grams 3. Admitted to the Neonatal Intensive Care Unit (NICU) at Bandung Kiwari General Hospital from October to December 2022 4. Diagnosed with respiratory distress syndrome (characterized by tachypnea, chest wall retraction, moaning, and Dawne Score > 4)

Exclusion criteria

Exclusion criteria: 1. Had already experienced severe respiratory distress 2. Were likely to develop respiratory failure requiring invasive ventilation 3. Declined to participate in the study

Design outcomes

Primary

Measure	Time frame
The following primary outcome measures were recorded every 15 minutes during the first 3 hours, and subsequently every 2 hours for a total observation period of 48 hours: 1. Peripheral capillary oxygen saturation (SpO2) measured using the sensors integrated into the multiparameter patient monitors available in the NICU 2. Fraction of inspired oxygen (FiO2) measured using data recorded directly from the CPAP or HFNC devices 3. Respiratory rate (RR) measured using the sensors integrated into the multiparameter patient monitors available in the NICU 4. Heart rate (HR) measured using the sensors integrated into the multiparameter patient monitors available in the NICU 5. Hypoxia in clinically respiratory distressed neonates measured using Downe's Score based on clinical findings	—

Measure

Time frame

The following primary outcome measures were recorded every 15 minutes during the first 3 hours, and subsequently every 2 hours for a total observation period of 48 hours: 1. Peripheral capillary oxygen saturation (SpO2) measured using the sensors integrated into the multiparameter patient monitors available in the NICU 2. Fraction of inspired oxygen (FiO2) measured using data recorded directly from the CPAP or HFNC devices 3. Respiratory rate (RR) measured using the sensors integrated into the multiparameter patient monitors available in the NICU 4. Heart rate (HR) measured using the sensors integrated into the multiparameter patient monitors available in the NICU 5. Hypoxia in clinically respiratory distressed neonates measured using Downe's Score based on clinical findings

—

Secondary

Measure	Time frame
Adverse events measured using observations during the study duration of 48 hours	—

Countries

Indonesia

Contacts

Public ContactReza Widianto Sudjud

reza.widianto.sudjud@unpad.ac.id+62 813-2000-3010

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026