Study Design, Methods & Measurements

The study, a pragmatic, multicentre, randomised, non-inferiority clinical trial, took place in 24 paediatric CCUS in NHS hospitals across Britain, from August 2019 to November 2021, with a final follow-up in March 2022.
 
Participants

Of the original sample group, the following children were excluded from the sample group:

• Children who had received respiratory support before admission.

• Children who had received either CPAP or HFNC 2 hours prior to the randomisation for this trial

• Children where the clinical decision had been made to commence a respirator support mechanism other than CPAP or HFNC

Age & Gender
 

The primary analysis included five hundred seventy-three children, aged between 36 weeks gestational age and 15 years of age, who had been admitted to the CCU with an acute illness, and in whom the decision was to administer non-invasive respiratory support. 

• 317 were younger than twelve years of age

• 228 were older than twelve years of age

• The median age was nine months.

• 226 of the children were girls

 

Reason for Admission
 

Nearly half of the children (275) had been admitted for Bronchiolitis, and the remaining children had been hospitalised for various respiratory diseases, including asthma or wheezing; cardiac conditions and other conditions such as sepsis.

Moderate to severe respiratory distress was recorded in 63% of the children, 42% of the participants had an: “SpO2:FIO2 ratio of less than 265, consistent with an oxygenation deficit usually seen in cases of paediatric acute respiratory distress syndrome.”


Trial Intervention

The 573 children included in the primary analysis were randomised in a one-to-one ratio to receive either HFNC or CPAP as follows:

• 295 children were given HFNC, with a flow rate based on patient weight.

• 278 children were given CPAP of 7- 8 cm H₂O
 

The randomised groups had similar baseline characteristics such as the reason for admission, level of respiratory distress, percentage of peripheral oxygenation saturation and fraction of inspired oxygenation.

Findings

Clinical Management
 

• 290 children received HFNC; 246 children received CPAP
• A variety of devices were used to deliver both the CPAP and the HFNC intervensions
• Treatment failure, requiring either a switch or an escalation, occurred in 96 of the children given HFNC, occurring within a median time of 6.1 hours, and in 131 of the CPAP group within a median of 4.5 hours. 
• More patients swapped from CPAP to HFNC. Only 25% of CPAP patients were still receiving CPAP therapy 24 hours after starting the treatment, compared to the almost 50% of children who received HFNC support. The patients who had switched were older, and discomfort was the main reason.
• Patients who swopped from HFNC to CPAP did so due to clinical deterioration 

The primary outcome of this study was to determine the time taken from the randomisation of treatment intervention to liberation from respiratory support. The researchers report that the median time from randomization to liberation in HHNC patients was 52.9 hours, and in CPAP was 47.9 hours from respiratory support.  This was determined to fall within the prespecified non-inferiority margin.

Of the six identified secondary outcomes:

• The rate of intubation within 48 hours was not significantly different between the two groups: HFNC 15.4%, CPAP 15.9%)
• Sedation use was lower in the HPFN group: 27.2% vs 37% in the CPAP group\
• The mean stay in CCU was significantly shorter in children receiving HFNC ( 5 days) vs children receiving CPAP ( 3.1 days)
• Parental stress levels were recorded as low for both groups

• Recorded adverse events were low in both groups: 8.1% in those patients receiving HFNC and 14% in patients receiving CPAP
• Four serious adverse events were recorded during the study, all cardiac arrests and all considered unrelated to the respiratory intervention
• Nasal trauma was the most commonly reported adverse effect, all in the CPAP group, with 6.5% of participants reporting this event

In Summary
 

The findings of this research can be broadly summarised as follows:

• Concerning the non-inferiority of first-line use of HFNC in acutely ill children when compared to the use of CPAP  in these children, no significant difference between the two was determined.

• In relation to their secondary findings:

  • The study showed that the use of sedation was significantly greater in the CPAP group than in the HFNC group( 37% vs 27,7%)
  • There was no reported difference in mortality between the two groups, nor was the rate of intubation statistically different.
  • While patients in the CPAP group had a longer mean duration of stay in both CCU and general hospital stay, the reasons for this were unclear
  • The scores from the COMFORT Behaviour Scale were similar
  • More children switched from CPAP to HFNC support, attributed to discomfort
  • There was no significant difference in parental stress scores between the two group
  • In terms of adverse findings, the CPAP group reported more nasal trauma

Conclusion

Based on their findings, Ramnarayan et al., conclude that first-line use of HFNC therapy in acutely ill children in a CCU setting was non-inferior to the use of CPAP in both time liberation from respiratory support and in secondary outcomes.


Back to top 

Reproduced under a Creative Commons Attribution-NonCommercial 4.0 International License 

Back to top