A randomised trial of a nasal barrier dressing to reduce nasal trauma in very preterm infants receiving continuous positive airway pressure (CPAP) or nasal intermittent positive pressure ventilation (NIPPV) treatment: The ProNose study.

Not Applicable

• Conditions: asal trauma in preterm infants receiving non invasive respiratory support treatment; Nasal trauma in preterm infants receiving non invasive respiratory support treatment; Injuries and Accidents - Other injuries and accidents; Respiratory - Other respiratory disorders / diseases; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12616000438459
• Lead Sponsor: eonatal Services, The Royal Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 206

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of nasal trauma during CPAP/NIPPV support defined as Stage 1-4 on the Royal Women's Hospital Nasal Integrity and Pressure Chart:<br>Stage 0: Skin in intact. No sign of redness. (No nasal trauma)<br>Stage 1:Non blanchable erythema of intact skin. (Intact unbroken skin)<br>Stage 2:Partial thickness skin loss involving epidermis, dermis or both. (Abrasion, tear, blister)<br>Stage 3:Full thickness skin loss involving damage to or necrosis of subcutaneous tissue<br>Stage 4:Full thickness skin loss with extensive destruction, tissue necrosis or damage to supporting structures<br><br>Nasal trauma scores will be performed by the bedside nurse three times in each 24-hour period whilst CPAP/NIPPV support is applied. <br>[The primary outcome period is: from randomisation, for a period of at least two weeks, and until the infant is >30 weeks post- menstrual age (PMA) and >1250 g weight, unless CPAP/NIPPV therapy is ceased earlier. ]