The use of Low Flow Nasal Prongs Therapy in weaning nasal Continuous Positive Airway Pressure (nCPAP) in neonates. Anecdotal or Evidence Based?

The use of Low Flow Nasal Prongs Therapy in weaning nasal Continuous Positive Airway Pressure (nCPAP) in neonates. A Multicentre Randomised Controlled Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN02529072

Enrollment

Registered

2010-02-24

Start date

2010-02-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome in very low birth weight infants. Neonatal Diseases Respiratory distress of newborn

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 fo

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: Neonates with associated congenital/respiratory/cardiac abnormality at the time of weaning of CPAP.

Design outcomes

Primary

Measure	Time frame
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 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.	—

Measure

Time frame

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 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

Measure	Time frame
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	—

Countries

Czech Republic, Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026