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comparison of high flow vs CPAP respiratory support in preterm infants more than 28 weeks gestation

Post INSURE administration of heated humidified high flow therapy versus nasal continuous positive airway pressure in preterm infants more than 28 weeks gestation with respiratory distress syndrome: A pilot trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/032081
Enrollment
30
Registered
2021-03-17
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: J22- Unspecified acute lower respiratory infection

Interventions

Intervention1: Heated humidified high flow nasal cannulae: respiratory medical device to support work of breathing in newborns Control Intervention1: Continuous positive airway pressure: respiratory m

Sponsors

Seth GS Medical College and KEM Hospital Mumbai
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All preterm infants more than 1 kg and more than 28 weeks gestational age with RDS who re-quire INSURE will be eligible for inclusion.

Exclusion criteria

Exclusion criteria: Preterm infants with any known major congenital abnormality will be excluded. Infants with oro-facial anomalies (cleft lip and palate, micrognathia) will also be excluded.

Design outcomes

Primary

MeasureTime frame
treatment failure within 7 daysTimepoint: treatment failure within 7 days—

Secondary

MeasureTime frame
1) To study the incidence and grades of nasal injuries 2) To study complications : Hemodynamically significant PDA (HS-PDA), Intra ventricular hemorrhage (IVH), sepsis, ventilator associate pneumonia, Chronic Lung Disease (CLD), Ret-inopathy of prematurity (ROP) Timepoint: 1 year—

Countries

India

Contacts

Public ContactAnitha Ananthan

Seth GS Medical College & KEM Hospital, Mumbai

ani.gem81@gmail.com02226201244

Outcome results

None listed

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