Contact information
Type
Scientific
Primary contact
Dr Jan Miletin
ORCID ID
Contact details
Neonatal Unit
Coombe Women and Infants University Hospital
Cork Street
Dolphin's Barn
Dublin
D8
Ireland
+353 (0)1 4085654
jmiletin@coombe.ie
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please contact the investigating unit to request a patient information sheet
Condition
Respiratory Distress Syndrome in very low birth weight infants.
Intervention
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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
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
Overall trial start date
01/02/2010
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
78
Participant exclusion criteria
Neonates with associated congenital/respiratory/cardiac abnormality at the time of weaning of CPAP.
Recruitment start date
01/02/2010
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Czech Republic, Ireland
Trial participating centre
Neonatal Unit,
Dublin
D8
Ireland
Sponsor information
Organisation
Coombe Women and Infants University Hospital (Ireland)
Sponsor details
Cork Street
Dolphin's Barn
Dublin
D8
Ireland
+353 (0)1 4085276
jmiletin@coombe.ie
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Coombe Women and Infants University Hospital (Ireland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23312683
Publication citations
-
Results
O'Donnell SM, Curry SJ, Buggy NA, Moynihan MM, Sebkova S, Janota J, Miletin J, The NOFLO trial: low-flow nasal prongs therapy in weaning nasal continuous positive airway pressure in preterm infants., J. Pediatr., 2013, 163, 1, 79-83, doi: 10.1016/j.jpeds.2012.12.007.