None listed
Conditions
Brief summary
Every year, thousands of babies are born early (premature). Many premature babies need help to breathe for several days after birth, and sometimes for much longer. The most commonly used way of supporting the breathing of premature infants is with a technique called nasal continuous positive airway pressure (NCPAP). NCPAP uses large prongs snugly fitted into the baby’s nostrils, kept in place by a tight-fitting hat. The prongs supply air or oxygen under pressure to help keep the baby’s lungs open, making it easier to breathe. NCPAP is a well-tried and tested method of breathing support, but has some disadvantages: the hat and tubing can be quite bulky and cover most of the baby’s face, and the large prongs can rub on the baby’s nose and sometimes cause damage to the skin. A newer form of breathing support being used around the world, and in Australia, is called high flow nasal cannulae (HFNC). This method uses smaller prongs in the baby’s nose and does not require a hat to hold the prongs in place. Like NCPAP, HFNC also supplies air or oxygen under pressure to help support the baby’s breathing. Because the prongs are smaller and less bulky, HFNC may be more comfortable for babies than NCPAP, and it is easier to see the baby’s face. For these reasons, HFNC has become very popular as treatment for premature babies, and is being used around the world. However, HFNC has not been widely studied as a way of supporting breathing for babies soon after birth. The HIPSTER trial will compare the use of these two types of breathing support as treatment for premature babies who have breathing difficulties soon after they have been born. Premature babies born after 28 weeks’ and before 37 weeks’ gestation, who need breathing support in the first 24 hours of life, will be able to join this study. Babies who join the study will be chosen at random to receive either NCPAP or HFNC. The study will include a total of 612 babies, 306 will be treated with each type of breathing support. The main thing we are interested in is whether babies are successfully treated with the type of breathing support they are given. Babies who are given HFNC and are not improving can be switched over to have NCPAP, to see whether that helps. Information will be collected about the babies, such as how long the babies in each group need to carry on with breathing support, whether they need extra breathing help, whether they get any damage to their nose from the prongs, and how well they feed and grow. Basic information will also be collected about the mothers of the babies and the pregnancy.
Interventions
High flow nasal cannula (HFNC) therapy. Heated, humidified, blended gas (air/oxygen) will be delivered at a flow rate of 4-8 L/minute using either Fisher & Paykel or Vapotherm circuits and nasal prongs. HFNC prong size will be selected as per the manufacturer's recommendations (maintaining a leak at the nares) and there will be no alterations to the manufacturer's recommended set-up of the circuit.
1. Infants randomised to HFNC will commence on flow rates of 6-8 L/min.
2. HFNC limits will be
High flow nasal cannula (HFNC) therapy. Heated, humidified, blended gas (air/oxygen) will be delivered at a flow rate of 4-8 L/minute using either Fisher & Paykel or Vapotherm circuits and nasal prongs. HFNC prong size will be selected as per the manufacturer's recommendations (maintaining a leak at the nares) and there will be no alterations to the manufacturer's recommended set-up of the circuit. 1. Infants randomised to HFNC will commence on flow rates of 6-8 L/min. 2. HFNC limits will be 4-8 L/min from trial entry until discharge home. 3. The attending clinical team will increase/decrease flow rates at their discretion in whole number flow increments (e.g. 4, 5, 6, 7, 8 L/min) and these changes will require a documented medical order. Infants should be reviewed at least every 24 hours and weaning considered if they are clinically improving with FiO2 (fraction of inspired oxygen) <0.30. 4. The flow rate should not exceed 8 L/min in any infant. 5. Infants who are stable on HFNC at 4 L/min, with FiO2 <0.30, for more than 24 hours, may cease HFNC and be tried in air or on low flow nasal cannulae (cessation at this stage is not mandatory; earlier cessation will be at the discretion of the attending clinical team if FiO2 <0.30). 6. Infants who satisfy failure criteria whilst receiving HFNC at 8 L/min will cease HFNC and receive ‘rescue’ NCPAP initially at 7-8 cm H2O (physician discretion). These infants will be deemed to have treatment failure for the primary outcome. Infants who subsequently again satisfy the failure criteria on NCPAP of 8 cm H2O, still within the primary outcome period of 72 hours, will be intubated and mechanically ventilated. 7. Should the decision be taken to recommence non-invasive respiratory support later during their admission (including post-extubation), infants in the HFNC group should again initially receive HFNC, unless they previously experienced treatment failure with HFNC. They may subsequently receive NCPAP at the discretion of the attending clinical team.
Sponsors
Professor Peter Davis
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 24 Hours
Healthy volunteers
No
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
Outcome results
None listed