|
ISRCTN
|
ISRCTN02529072
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
The use of Low Flow Nasal Prongs Therapy in weaning nasal Continuous Positive Airway Pressure (nCPAP) in neonates. Anecdotal or Evidence Based?
|
|
Scientific title
|
The use of Low Flow Nasal Prongs Therapy in weaning nasal Continuous Positive Airway Pressure (nCPAP) in neonates. A Multicentre Randomised Controlled Trial
|
|
Acronym
|
NOFLO Trial
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
The aim of the study is to determine if improved weaning of neonates less than 1500g from nCPAP can be observed using low flow nasal prongs therapy versus self ventilation after minimal nCPAP settings have been reached. We hypothesise that low flow nasal prong therapy will decrease failure rate of weaning.
|
|
Lay summary
|
Not provided at time of registration
|
|
Ethics approval
|
1. Research Ethics Committee, Coombe Women and Infants University Hospital, Dublin, Ireland approved on the 23rd of September 2009 (ref: 18 - 2009)
2. Ethics Commitee of Institute for Clinical and Experimental Medicine and Faculty of Thomayer Hospital, Prague, Czech Reupublic approved on the 13th of January 2010 (ref: 2500 - 09 [A 10-01-03])
|
|
Study design
|
Multicentre randomised controlled parallel group trial
|
|
Countries of recruitment
|
Czech Republic, Ireland
|
|
Disease/condition/study domain
|
Respiratory Distress Syndrome in very low birth weight infants.
|
|
Participants - 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.
|
|
Participants - exclusion criteria
|
Neonates with associated congenital/respiratory/cardiac abnormality at the time of weaning of CPAP.
|
|
Anticipated start date
|
01/02/2010
|
|
Anticipated end date
|
31/12/2010
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please contact the investigating unit to request a patient information sheet
|
|
Target number of participants
|
78
|
|
Interventions
|
Intervention Group: Use of Low Flow Nasal Prongs therapy for weaning from nCPAP.
Control Group: Self Ventilation on weaning from nCPAP.
Study duration and monitoring will be for 5 consecutive days following weaning from nCPAP
|
|
Primary outcome measure(s)
|
Failure rate of weaning from nCPAP. Failure of weaning defined by:
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.
2. Need for Oxygen to maintain saturations >85%.
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.
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 measure(s)
|
1. Length of time to failure
2. Changes in status, assessed hourly
2.1. heart rate
2.2. respiratory rate
2.3. saturations
2.4. frequency of apnoeas
3. Change in Silverman - Anderson Respiratory Score, assessed every 4 hours
|
|
Sources of funding
|
Coombe Women and Infants University Hospital (Ireland)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Jan
Miletin
|
|
Address
|
Neonatal Unit,
Coombe Women and Infants University Hospital,
Cork Street,
Dolphin's Barn,
|
|
City/town
|
Dublin
|
|
Zip/Postcode
|
D8
|
|
Country
|
Ireland
|
|
Tel
|
+353 (0)1 4085654
|
|
Email
|
jmiletin@coombe.ie
|
|
Sponsor
|
Coombe Women and Infants University Hospital (Ireland)
|
|
Address
|
Cork Street,
Dolphin's Barn
|
|
City/town
|
Dublin
|
|
Zip/Postcode
|
D8
|
|
Country
|
Ireland
|
|
Tel
|
+353 (0)1 4085276
|
|
Fax
|
+353 (0)1 4536033
|
|
Email
|
jmiletin@coombe.ie
|
|
Date applied
|
02/02/2010
|
|
Last edited
|
11/10/2011
|
|
Date ISRCTN assigned
|
24/02/2010
|
