asal High-Frequency Oscillation to Improve Respiratory Stability of Preterm Infants: A Randomized Crossover Study

Not Applicable

Completed

• Conditions: Desaturations and bradycardias related to apnoea of prematurity; Reproductive Health and Childbirth - Childbirth and postnatal care; Respiratory - Other respiratory disorders / diseases; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12616001516471
• Lead Sponsor: The Royal Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Gestational age at birth: < 30 weeks
- Postmenstrual age: greater than or equal to 26 and < 34 completed weeks of gestation
- Postnatal age: > 7 days
- Respiratory support: Receiving nasal CPAP and extubated for greater than or equal to 24 hours.

Exclusion Criteria

- Participation in another study that prohibits inclusion
- Nasal trauma and Pressure Injury score greater than or equal to 2 (stage 2: partial thickness skin loss involving epidermis, dermis or both) before study entry

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in the total number of desaturations and bradycardias between CPAP and nHFO treatment during 120-minute recording periods for each therapy.[120 minutes of nHFO (intervention period) compared to 120 minutes of CPAP (baseline period).<br><br>An oximetry sensor (LNOP Neo sensor; Masimo, Irvine, California, USA) will be placed around the infant’s wrist or foot and connected to the pulse oximeter (Radical7 V5; Masimo, 2 second averaging mode). Continuous data will be recorded using a neonatal respiratory monitor (NewLifeBox Neo-RSD, Advanced Life Diagnostics UG, Weener, Germany).]