High Flow Nasal Cannulae as Primary Support in the Treatment of Early Respiratory Distress (The HIPSTER Trial)

Not Applicable

Completed

• Conditions: Respiratory distress of the newborn; Respiratory - Other respiratory disorders / diseases; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12613000303741
• Lead Sponsor: Professor Peter Davis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-19
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 750

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is treatment failure within 72 hours after initiation of the assigned treatment. To fail the assigned treatment, the infant must be receiving maximal therapy (NCPAP 8 cm H2O or HFNC 8 L/min), plus at least one of:<br><br>- Sustained fraction of inspired oxygen (FiO2) requirement 0.40 or more to maintain peripheral oxygen saturation (SpO2) within the specified normal limits of the participating centre<br>- pH 7.20 or lower and pCO2 >60 mm Hg on free-flowing capillary or arterial blood gas sample, taken at least 1 hour after initiation of assigned treatment<br>- Six or more apnoeas requiring intervention (not self-resolving) within any 6-hour period, or 2 or more apnoeas requiring positive pressure ventilation within any 24-hour period<br><br>Treatment failure will also be adjudged to have occurred in any infant requiring urgent intubation and mechanical ventilation (at medical discretion)<br>[72 hours after initiation of allocated treatment.]