Comparison of two devices for breathing support in newborn babies

Not Applicable

Completed

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

• Registration Number: ACTRN12619000535178
• Lead Sponsor: Fisher & Paykel Healthcare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-03
• Study Completion: 2019-12-17
• Last Update Posted: 10 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

•Born at GA greater than or equal to 33 weeks
•Clinical decision that the baby should continue BCPAP therapy for the next 6 hours
•Infant is stable for >4 hours on a BCPAP pressure of 6 cmH2O and 6 L/min with no oxygen requirement, with a respiratory rate of <60 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 BCPAP.
•Prenatal asphyxia (Apgar score less than 3 at minute 5, Cord pH less than 7, and cord bicarbonate less than 12)
•Infants with notifiable diseases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in mean SpO2 level between intervention and control phases, as recorded from the pulse oximeter, [Mean SpO2 is averaged over the 30-minute intervention and 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 control study 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 control study phases];Adverse events that occur during the trial will be recorded as reported in medical records. These include nasal trauma, pulmonary air leaks, apnea, abdominal distension, intestinal perforation, necrotizing enterocolitis [ Through out the four 30 minute intervention and control phases.]