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Will intermittent changing of nasal interfaces reduce nasal injury in neonates on CPAP? - A randomized control trial

Can rotation of nasal interfaces decrease the incidence of nasal injury in neonates on nasal CPAP?: A Randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/04/008368
Enrollment
192
Registered
2017-04-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Respiratory distress syndrome

Interventions

Intervention1: Rotation group: The appropriate sized Drager mask and Hudson prongs will be rotated every 8 hourly (each nursing shift) for delivering CPAP. Care will be taken during these changes to m

Sponsors

Fernandez Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All inborn neonates less than 31 weeks of gestation and developed respiratory distress (presence of at least two out of three signs: tachyp-nea >60/min, intercostal retractions, and expiratory grunt) within 6 hours of life

Exclusion criteria

Exclusion criteria: Neonates with Perinatal depression (5 minute Apgar score of and Conditions where CPAP would be contraindicated such as neonates with poor spon-taneous respiratory efforts or apnea, worsening shock, suspected or proven persistent pulmonary hypertension of newborn, severe metabolic acidosis (pH -10), severe respiratory acidosis (pH 55mmHg) and mas-sive pulmonary hemorrhage

Design outcomes

Primary

MeasureTime frame
Incidence and severity of nasal injury at removal of CPAP and at discharge from the NICU based on the objective scoring and a subjective assessmentTimepoint: At stoppage of CPAP

Secondary

MeasureTime frame
Duration of CPAPTimepoint: Discharge;incidence of bronchopulmonary dysplasiaTimepoint: Discharge;Intraventricular hemorrhageTimepoint: Discharge;Need for mechanical ventilationTimepoint: 7 days;Periventricular leukomalaciaTimepoint: Discahrge;Ventilator associated pneumoniaTimepoint: Till 2 days after removal of CPAP

Countries

India

Contacts

Public ContactDr Tejopratap oleti

Fernandez hospital

tejopratap@gmail.com

Outcome results

None listed

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