Imbulana DI, Owen LS, Dawson JA, Bailey JL, Davis PG, Manley B. A Randomized Controlled Trial of a Barrier Dressing to Reduce Nasal Injury in Preterm Infants Receiving Binasal Noninvasive Respiratory Support. The Journal of Pediatrics 2018; 10.1016/ j.jpeds.2018.05.026.
David N. Matlock, Jr., MD
University of Arkansas for Medical Sciences
TYPE OF INVESTIGATION
(P) In infants less than 30 weeks’ gestation and/or with birth weight less than 1250 grams receiving nasal continuous positive airway pressure (NCPAP), does the use of a barrier dressing (I) compared with no barrier dressing (C) decrease the incidence of nasal injury (O) when used until the infant achieves both 30 weeks’ postmenstrual age and 1250 grams current weight (T)?
- Design: Prospective, randomized, single center. Approved by local review board and prospectively registered with the Australian and New Zealand Clinical Trials Registry.
- Allocation: Allocation concealed.
- Blinding: Partially blinded. Some of the outcome assessors were blinded, although the bedside nurses documenting the assessment for the primary outcome were not blinded to the study intervention.
- Follow-up period: Infants were followed until they achieved 36 weeks’ postmenstrual age.
- Setting: Single neonatal intensive care unit in Melbourne, Australia.
- Patients: Infants less than 30 weeks’ gestational age and/or with birth weight <1250 grams treated with NCPAP.
- Inclusion Criteria: Less than 30 weeks’ gestational age and/or with birth weight <1250 grams treated with NCPAP.
- Exclusion Criteria: NCPAP treatment beginning at ≥30 weeks’ postmenstrual age or weight ≥1250 grams, NCPAP for ≥48 hours prior to randomization, previous documented nasal injury, facial features precluding NCPAP treatment (e.g., choanal atresia).
- Intervention: For neonates randomized to the treatment group, the appropriate size Neo-Guard nasal barrier dressing, an adherent hydrocolloid dressing, was placed between the infant’s skin and the NCPAP interface. This dressing was not used for infants in the no-barrier group.
- Primary outcome: Rate of any nasal injury as assessed and recorded by bedside nurses using a standardized staging chart.
- Secondary outcomes: Stage of nasal injury assessed by bedside nurses, presence and stage of injury as assessed via photograph by a blinded evaluator, respiratory outcomes, common neonatal morbidities, and dressing cost.
- Analysis and sample size: Estimating the rate of the primary outcome would be 50% in the control group, and assuming a 40% relative reduction, a sample size of 206 infants was calculated to achieve 80% power (α 0.05). Due to slower than anticipated recruitment, only 108 infants were randomized (53 to barrier group, 55 to no barrier group). Analysis was based on the intention-to-treat, and gestational age subgroups were analyzed for the primary outcome.
- Patient follow-up: Of the enrolled infants, 108 (100%) were analyzed for the primary outcome and followed until 36 weeks’ postmenstrual age for secondary outcomes.
The reported characteristics of the mothers and infants, which included ethnicity, antenatal steroid exposure, labor prior to delivery, Cesarean delivery, prolonged rupture of membranes, gestational age, birth weight, sex, Apgar scores, surfactant treatment, caffeine treatment, duration of endotracheal ventilation, and duration of CPAP prior to randomization, were similar between the groups with no difference reaching statistical significance using a P value of <0.05.
For the primary outcome, any nasal injury documented by bedside nurses occurred in 18 of 53 infants (34%) in the barrier group and 31 of 55 (56%) in the no barrier group, P = 0.02.
|Nasal Barrier N=53||No Nasal Barrier N=55||P value|
|Any nasal injury documented by bedside nurse n(%)||18 (34)||31 (56)||0.02|
With bedside nurses using a standardized staging chart, a difference was detected in severity of nasal injury with less severe nasal injury in the barrier group vs. the no barrier group. There were no differences in other reported outcomes, which included severity of injury reported by a blinded observer on nasal photograph, maximum set CPAP pressure, maximum sustained supplementary oxygen requirement, re-intubation during study, pneumothorax, corticosteroid use, major neonatal morbidities, and death.
|No Nasal Barrier
|Incidence of Nasal Injury Staging
|No injury||35(66)||24 (44)||0.02*|
|Stage 1||13 (25)||25 (45)|
|Stage 2||5 (9)||6 (11)|
|Stage 3/4||0 (0)||0 (0)|
|Incidence of nasal injury on photograph by blinded observer n/N (%)||10/50 (20)||16/48 (33)||0.14|
*P value for linear trend for severity of nasal injury, stages 0-4.
The authors conclude that the use of a nasal barrier dressing is a cost-effective way to reduce the incidence and severity of nasal injury in premature infants receiving NCPAP.
Most widely used and effective interfaces to provide “non-invasive” respiratory support to infants involve binasal prongs, which rely upon a tight fit at the nares to transmit pressure to the distal airways, preventing atelectasis and maintaining functional residual capacity (1). NCPAP-related nasal injury is a common complication of these interfaces (2). Special dressings have been manufactured to prevent this complication, and have been found to be effective in larger infants (3, 4, 5). The current study aimed to evaluate a barrier dressing in smaller, less mature infants.
This manuscript described a single-center, prospective, randomized trial comparing the use of a nasal barrier dressing to no dressing for the prevention of nasal injury in premature neonates (<30 weeks’ gestation and/or <1250 grams) receiving NCPAP. The primary outcome was nasal injury as evaluated by the bedside nursing staff each shift using a standardized chart and staging system. Secondary outcomes included relevant respiratory outcomes as well as common neonatal morbidities and mortality. An additional secondary outcome involved assessment of nasal injury on photograph by a blinded evaluator.
Although the study aimed to achieve 80% power to detect a 40% relative reduction in the primary outcome, the recruitment goal was not reached, and the study was stopped early after 16 months due to slow enrollment. No infants were lost during the follow up period (until 36 weeks’ postmenstrual age). Despite not reaching the accrual goal, the investigators were able to demonstrate a reduction in nasal injury with the use of the dressing with a number needed to treat of five infants to prevent one injury. The cost analysis demonstrated that the intervention is cost effective at the study center. The study was underpowered for the subgroup analyses as reported.
A weakness of the study relates to the assessment of the primary outcome. The bedside nurses documenting the presence and stage of nasal injury were not blinded to the treatment, introducing risk for bias. Additionally, their ability to assess for nasal injury was often limited by the presence of the nasal barrier, which obstructed the view of the area to be examined. Using photographs and a blinded evaluator would have helped overcome these limitations. This was attempted, but there were a limited number of photographs available for assessment, and ten infants had no photograph at all. This, along with the limited power of the study, renders the finding of no difference between groups in incidence of nasal injury as found by the blinded observer difficult to interpret.
Further research is required into the optimal material, design, and protocol for the use of nasal barrier dressings in neonates receiving non-invasive respiratory support. Future studies should blind evaluators to the intervention to reduce the risk for bias. While further study is needed, three prospective trials have now demonstrated the efficacy of barrier dressings at preventing NCPAP-associated nasal injury (2, 3, 4). Therefore, consideration should be given to the immediate adoption of nasal barrier dressings as a cost-effective method to prevent nasal injury in this population.
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