None listed
Conditions
Brief summary
Small and premature babies often need help to breathe after birth, sometimes for many weeks. Established methods of providing breathing support are Continuous Positive Airway Pressure (CPAP) and Nasal Intermittent Positive Pressure Ventilation (NIPPV). CPAP and NIPPV use warmed air and oxygen given into the baby’s nose using small soft plastic prongs. This is very effective, but sometimes the plastic prongs can cause the skin in and around the nose to become sore or damaged. Skin damage is particularly common during CPAP /NIPPV treatment in very preterm and tiny babies. The aim of the ProNose study is to see whether using a barrier dressing over the nose can reduce damage to the nose in very small babies receiving CPAP/NIPPV. To work out whether the barrier makes a difference, we organise babies receiving CPAP/NIPPV into two groups one group will have the barrier dressing and the other will not. The group results are then compared to see if there is any difference in the number of babies who get a sore nose. Babies can join this study if they are born before 30 weeks' gestation or weigh less than 1250 grams at birth, and need CPAP/NIPPV treatment. Some babies will need this from soon after birth; other babies will need support from a ventilator (breathing machine) to begin with, and become ready for CPAP/NIPPV later on. When a baby is ready to start CPAP/NIPPV, or soon after they have started this, babies will be randomly placed in one of the two study groups: (1) using the barrier dressing (BARRIER group) or (2) normal care – without the barrier dressing (NO BARRIER group). Babies in the BARRIER group will have the barrier dressing applied within the hour, and will continue to have the barrier dressing whenever they are receiving CPAP/NIPPV for at least 2 weeks, or until they are 30 weeks from the start of pregnancy and weigh more than 1250 grams, unless they stop CPAP/NIPPV before then. The barrier dressing material will be replaced when required, as assessed by the clinical teams. Babies in both groups will be followed for the study throughout their time at the Women’s. We will also take regular photographs of babies' noses whilst they are in this study and on breathing support. This is so that we can objectively assess whether there is any injury to the nose. The ProNose study will enroll 206 babies at the Women’s and will take about 18 months to complete.
Interventions
Infants in the intervention group will have a Hydrocolloid nasal barrier dressing (Duoderm- a Polyurethane film coated with adhesive mass) applied by a neonatal intensive care unit (NICU) nurse over their nose within 1 hour of randomisation whilst receiving Continuous Positive Airway Pressure (CPAP) support or nasal intermittent positive pressure ventilation (NIPPV). This dressing will be applied within an hour of randomisation. The nasal barrier dressing size will be chosen as per the manufactu
Infants in the intervention group will have a Hydrocolloid nasal barrier dressing (Duoderm- a Polyurethane film coated with adhesive mass) applied by a neonatal intensive care unit (NICU) nurse over their nose within 1 hour of randomisation whilst receiving Continuous Positive Airway Pressure (CPAP) support or nasal intermittent positive pressure ventilation (NIPPV). This dressing will be applied within an hour of randomisation. The nasal barrier dressing size will be chosen as per the manufacturer's guidelines. The nasal barrier dressing provided by the manufacturer include velcro strips which can be used to maintain stable movement of prongs on the barrier dressing. The nasal barrier dressing will continue to be applied during CPAP/NIPPV treatment for a period of at least two weeks, or until the infant is >30 weeks post menstrual age and >1250g, whichever is longer. The barrier dressing will be routinely changed every 72 hours. Photographs of the nose without prongs in situ and with the barrier dressing removed will be taken at least twice weekly. The barrier dressing should be changed if it is no longer adherent to the infants' skin, if the dressing is damaged, or if there is a clinical need for access or visualisation of the area. The NICU nurse will assess the nose and upper lip area. A nasal trauma score will be generated and documented every time the nasal barrier dressing is changed and during every nursing care episode.
Sponsors
Neonatal Services, The Royal Women's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 3 Months
Healthy volunteers
No
Inclusion criteria
1. Preterm infants <30 weeks' GA at birth or birth weight <1250 g, and 2. Commencing CPAP/NIPPV at <30 weeks' corrected GA or at <1250 g current weight, whether previously mechanically ventilated or not, and 3. Are expected to require at least 4 hours of CPAP support and 4. Have received <48 hours of continuous CPAP/NIPPV support prior to consent being obtained.
Exclusion criteria
1. Gestation at birth 30 weeks' or above, and birth weight 1250 g or above. 2. Received 48 hours or more of continuous CPAP/NIPPV support prior to consent and randomisation. 3. Received 48 hours or more of CPAP/NIPPV support prior to consent and randomisation 4. Expected to receive <4 hours of CPAP support. 5. Infants with any documented nasal trauma prior to enrolment. 6. Facial features potentially precluding the use of binasal CPAP/NIPPV e.g. clept lip or palate, Pierre Robin Sequence, choanal atresia.
Outcome results
None listed