Comparison of two variable-flow CPAP devices for respiratory support in premature infants

Not Applicable

Recruiting

• Conditions: Premature birth; Respiratory disease; Reproductive Health and Childbirth - Complications of newborn; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12623000203651
• Lead Sponsor: Fisher & Paykel Healthcare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-24
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Born at GA equal to or greater than 34 weeks
• Clinical decision that the baby should continue variable-flow CPAP therapy for the next 6 hours
• Infant is stable for >3 hours before 1 hour observation period on a variable-flow CPAP pressure between 4 and 10 cmH2O with FiO2 less than or equal to 0.3 oxygen requirement, with a respiratory rate of <70 breaths/min and without significant desaturation or bradycardia events (defined at spontaneous events with oxygen saturation levels < 80%, heart rate <100 beats/min and requiring nursing intervention).
• Infants will be discussed with the attending neonatologist as to their suitability relative to the study protocol on the morning ward round, and the ultimate discretion remains at all times with the neonatologist responsible for the infant’s care.

Exclusion Criteria

• Infants with congenital abnormalities, suspected chromosomal abnormalities or other conditions which would exclude the use of variable-flow CPAP.
• Prenatal asphyxia (Apgar score less than 5 at minute 5, Cord pH less than 7, and Lactate > 6)
• Infants with notifiable diseases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in SpO2 between intervention and control study phases as recorded from the pulse oximeter, with a noninferiority margin of 2% points.[ Mean SpO2 is averaged over the 30-minute intervention and 60-minute control study phases]

Secondary Outcome Measures

Name	Time	Method
Difference in mean heart rate between intervention and control study phases, as recorded from the patient monitor[ Mean heart rate is averaged over the 30-minute intervention and 60-minute control study phases.];To assess the safety of the neonatal flow generator by recording adverse events and any other relevant safety parameters per treatment, as reported in the medical records.[ Throughout the 4.5 hour observation period (includes all intervention and control phases).];Difference in mean respiratory rate between intervention and control study phases, as recorded from the patient monitor[ .Mean respiratory rate is averaged over the 30-minute intervention and 60-minute control study phases.]