ACTRN12613000303741Completed未知
A multi-centre, randomised, controlled, non-inferiority trial comparing high flow nasal cannulae to nasal continuous positive airway pressure as primary respiratory support, in preterm infants of 28 weeks' gestation and above, with early respiratory distress or apnoea, assessing assigned treatment failure within 72 hours.
Professor Peter Davis0 sites750 target enrollmentStarted: March 19, 2013Last updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 750
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- o limit to 24 Hours (—)
- Sex
- All
Inclusion Criteria
- •1.Preterm infants of at least 28 weeks and <37 weeks’ GA at birth by best obstetric estimate
- •2.Age <24 hours
- •3.Admitted to the neonatal intensive care unit (NICU) of a participating centre, whether inborn or outborn
- •4.Prospective parental consent obtained
- •5.Decision has been made, at or after admission to the NICU, by the attending clinician, to commence or continue non-invasive respiratory support (some infants may have received a brief period of NCPAP prior to admission to the NICU, as part of their standard care during resuscitation/stabilisation at delivery and/or during transfer from the birth centre or theatre)
- •6.At randomisation, infant has received <4 hours NCPAP support
- •7.Full intensive care is being offered
Exclusion Criteria
- •1.GA <28 weeks, or 37 weeks and above, at birth
- •2.Previous intubation and mechanical ventilation, or immediate need for intubation and mechanical ventilation, as determined by the attending clinician
- •3.Any infant who is receiving NCPAP 8 cm H2O and already satisfying the treatment failure criteria, as specified above
- •4.Any infant who has received 4 hours or more of NCPAP support
- •5.Participation in a concurrent study that prohibits inclusion in this trial
- •6.Known major upper airway, lower respiratory tract, cardiac or gastrointestinal tract anomaly
- •7.Known air leak syndrome
Investigators
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