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Comparing two modalities of treatment in children who have breathing difficulty and less oxygen in the blood. One modality is providing oxygen at high flow and heated and humidified by a machine. Other modality is providing heated and humidified oxygen at continuous positive pressure.

To study the efficacy of HHFNC in children admitted with acute hypoxemic lung injury in comparison with CPAP.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013165
Enrollment
264
Registered
2018-04-11
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: J960- Acute respiratory failure Health Condition 2: null- HYPOXEMIA

Interventions

Intervention1: Heated humidified high flow nasal cannula(HHFNC): HFNC is used to provide oxygen in children with respiratory distress. Control Intervention1: continuous positive airway pressure(CPAP):

Sponsors

Rainbow Childrens Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 All children in the age group of 1 month to 18 yrs having P/F ratio less than 300 or S/F ratio less than 260.

Exclusion criteria

Exclusion criteria: 1 Children with Severe encephalopathy with Glasgow Coma Scale of below 9 2 Children with poor airway reflexes/ Inadequate spontaneous efforts/inability to clear secretions for example central neurogenic disorder with inability to maintain airway or neuromuscular/musculoskeletal disorders 3 Children with severe shock with multiorgan dysfunction. 4 Children with facial trauma and burns 5 Children with nasal septal defect

Design outcomes

Primary

MeasureTime frame
To compare the oxygenation status in both groups. Timepoint: At 1 hrs,6 hrs,24 hrs and 48 hrs. After the calculated sample size of 264 patients with around 132 patients in each arms is reached. This may take December 2018

Secondary

MeasureTime frame
To assess the need for adjunctive respiratory support in the form of need to shift over to CPAP/NIV/INTUBATION for children on HHFNC or NIV/INTUBATION for children on CPAP To assess patient comfort ,mortality ,morbidity , length of stay , PICU stay, atelectasis scoreTimepoint: Time point will depend on the response of the patient. After reaching the calculated sample size of 264 patients which will be roughly 132 patients in each arm by December 2018

Countries

India

Contacts

Public ContactDr Shashwat Mohanty

Department of Pediatric Intensive Care

farhanshaikh74@gmail.com9866007602

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 15, 2026