The use of Low Flow Nasal Prongs Therapy in weaning nasal Continuous Positive Airway Pressure (nCPAP) in neonates. Anecdotal or Evidence Based?
| ISRCTN | ISRCTN02529072 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02529072 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/02/2010
- Registration date
- 24/02/2010
- Last edited
- 04/09/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jan Miletin
Scientific
Scientific
Neonatal Unit
Coombe Women and Infants University Hospital
Cork Street
Dolphin's Barn
Dublin
D8
Ireland
| Phone | +353 (0)1 4085654 |
|---|---|
| jmiletin@coombe.ie |
Study information
| Study design | Multicentre randomised controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please contact the investigating unit to request a patient information sheet |
| 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 |
| Study acronym | NOFLO Trial |
| Study objectives | 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(s) | 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]) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/02/2010 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 78 |
| Key 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. |
| Key exclusion criteria | Neonates with associated congenital/respiratory/cardiac abnormality at the time of weaning of CPAP. |
| Date of first enrolment | 01/02/2010 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Czech Republic
- Ireland
Study participating centre
Neonatal Unit,
Dublin
D8
Ireland
D8
Ireland
Sponsor information
Coombe Women and Infants University Hospital (Ireland)
Hospital/treatment centre
Hospital/treatment centre
Cork Street
Dolphin's Barn
Dublin
D8
Ireland
| Phone | +353 (0)1 4085276 |
|---|---|
| jmiletin@coombe.ie | |
"ROR" |
https://ror.org/00bx71042 |
Funders
Funder type
Hospital/treatment centre
Coombe Women and Infants University Hospital (Ireland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2013 | Yes | No |
