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
Protocol serial number	N/A
Sponsor	Coombe Women and Infants University Hospital (Ireland)
Funder	Coombe Women and Infants University Hospital (Ireland)

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

Neonatal Unit
Coombe Women and Infants University Hospital
Cork Street
Dolphin's Barn
Dublin
D8
Ireland

Phone	+353 (0)1 4085654
Email	jmiletin@coombe.ie

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(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.
Key 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
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes