The use of Low Flow Nasal Prongs Therapy in weaning nasal Continuous Positive Airway Pressure (nCPAP) in neonates. Anecdotal or Evidence Based?

Completed

Conditions: Respiratory Distress Syndrome in very low birth weight infants.
Neonatal Diseases
Respiratory distress of newborn

Registration Number: ISRCTN02529072

Lead Sponsor: Coombe Women and Infants University Hospital (Ireland)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 78

Inclusion Criteria

1. Neonates with a birth weight of 1500g or less.
2. Ventilation support for a minimum of 48 hours (including nCPAP), with successful weaning to an oxygen concentration of room air.
3. Maintenance on a minimum end expiratory pressures of 3-5 cm of H2O on nCPAP. The neonate must be comfortably maintained on these nCPAP settings without significant apnoea or respiratory distress for at least 24 hours.

Exclusion Criteria

Neonates with associated congenital/respiratory/cardiac abnormality at the time of weaning of CPAP.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Failure rate of weaning from nCPAP. Failure of weaning defined by:<br>1. More than one self correcting apnoeic episode per hour (defined as a bradycardia < 100/min with concurrent saturations of less than 80% lasting = 20 seconds) or one apnoeic episode requiring either stimulation or bag and mask ventilation.<br>2. Need for Oxygen to maintain saturations >85%.<br>3. A score of 6-10 on the Silverman-Anderson Respiratory Scale. This is an evaluation of respiratory status and work of breathing. A score of 6-10 will indicate moderate to severe respiratory distress.<br>If these criteria are reached they will be placed back on nCPAP at the settings they had been maintained on at the time of weaning.

Secondary Outcome Measures

Name	Time	Method
1. Length of time to failure<br>2. Changes in status, assessed hourly<br>2.1. heart rate<br>2.2. respiratory rate<br>2.3. saturations <br>2.4. frequency of apnoeas<br>3. Change in Silverman - Anderson Respiratory Score, assessed every 4 hours