Condition category
Neonatal Diseases
Date applied
02/02/2010
Date assigned
24/02/2010
Last edited
04/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes