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Optimum oxygenation of babies in ventilator support (CPAP)

Closed Loop FiO2: Optimal Manual Control - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2013/05/003621
Enrollment
20
Registered
2013-05-08
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- RDS (Respiratory Distress Syndrome)

Interventions

None listed

Sponsors

Philips Electronics India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates who are more than 26 weeks and who are on CPAP

Exclusion criteria

Exclusion criteria: (i) Neonates with major congenital anomalies, severe birth asphyxia, chest X ray suggestive of congenital diaphragmatic hernia or other developmental anomalies of lungs; (ii) Post-surgical babies, particularly for gastro-intestinal surgery involving necrotizing enterocolitis; (iii) babies experiencing side effects of narcotic drug use by the birth mother during pregnancy.

Design outcomes

Primary

MeasureTime frame
To analyze the feasibility of having automated FiO2 adjustments from the CLFiO2 algorithm. An optimal manual control would be taken as reference; this will be done by having a dedicated bedside caregiver. The suggestions provided by the CLFiO2 algorithm will be matched with the adjustments made by the dedicated caregiver.Timepoint: 2 hours from the start of the study

Secondary

MeasureTime frame
1) To calculate the number of events of hypoxemia and hyperoxemia 2) To estimate the effort of caregiver in terms of FiO2 adjustments 3) Understanding situations when the controller algorithm matches with the dedicated caregiver and when it does not Timepoint: 2 hours from the start of the study

Countries

India

Contacts

Public ContactNavaneetha Krishnan

Philips Research India - Bangalore

Navaneetha.Krishnan@philips.com080-41890000

Outcome results

None listed

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