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Nasal interfaces for CPAP- what is best for the preterm infant?

Nasal mask versus Nasal prongs in the delivery of Continuous positive airway pressure in preterm infants â?? an open label randomised controlled trial - none

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/08/002868
Enrollment
72
Registered
2012-08-07
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- Preterm infants between 26-32 weeks gestation requiring continuous positive airway pressure

Interventions

Intervention1: Nasal mask: Application of continuous positive airway pressure (CPAP) through nasal CPAP masks available in 3 sizes. This is to be given continuously till the baby has respiratory distr

Sponsors

All India Institute of medical sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm babies of 26+0 â?? 32+6 weeks of gestation Respiratory distress requiring CPAP within 6 hours of life Informed parental consent

Exclusion criteria

Exclusion criteria: Major congenital malformations Any known anomaly known to interfere with delivery of CPAP such as congenital diaphragmatic hernia, trachea oesophageal fistula, choanal atresia, cleft palate and nasal deformities, severe cardiovascular instability.

Design outcomes

Primary

MeasureTime frame
1. Area under the curve of FiO2 against time during the first 72 hours of CPAP application 2. Mean FiO2 requirement at 24 , 48 and 72 hours of CPAPTimepoint: 1. Area under the curve of FiO2 against time during the first 72 hours of CPAP application 2. Mean FiO2 requirement at 24 , 48 and 72 hours of CPAP

Secondary

MeasureTime frame
1. Proportion of babies requiring intubation in the first 72 hours of life 2. Proportion of babies who develop nasal trauma 3. Physiological variables including the mean respiratory rates and heart rates as well as Silvermanâ??s score during the first 72 hours 4. Incidence of oxygen dependency at 28 days postnatal life, air leaks Timepoint: Physiological variables are measured at baseline and at 1, 2, 6, 12, 18, 24 hours and every 6th hourly thereafter until 72 hours of CPAP. Nasal trauma will be graded by an independent observer daily during first 72 hours till CPAP is removed

Countries

India

Contacts

Public ContactAparna Chandrasekaran

All India Institute of Medical sciences, New Delhi

ashokdeorari_56@hotmail.com9818131391

Outcome results

None listed

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