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Utility of automated control of oxygen delivery in preterm infants

Influence of closed loop automated control of oxygen (CLACO) on time spent by the infant within the target saturation range, and oxygen requirement in South Indian preterm infants under 34 weeks. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067066
Enrollment
50
Registered
2024-05-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: J840- Alveolar and parieto-alveolar conditions Health Condition 2: J840- Alveolar and parieto-alveolar conditions Health Condition 3: J840- Alveolar and parieto-alveolar conditions

Interventions

Intervention1: Closed loop automated control of oxygen (Oxygenie, SLE 6000): Each baby requiring respiratory support, will spend 8 hours monitored by closed loop automated control of oxygen (Oxygenie,

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Infants born under 34 weeks gestation who require respiratory support, either invasive or non-invasive ventilation, for a medical indication.

Exclusion criteria

Exclusion criteria: Babies with any congenital malformation including congenital heart disease, diaphragmatic hernia, cystic pulmonary airway malformation or any other cardio respiratory malformation were excluded.

Design outcomes

Primary

MeasureTime frame
Proportion of time spent by the infants within the target oxygen saturation range will be compared between CLACO arm and MCO arm.Timepoint: 16 hours—

Secondary

MeasureTime frame
Concentration of FiO2 required to maintain target oxygen saturation compared between CLACO arm and MCO arm.Timepoint: 16 hours—

Countries

India

Contacts

Public ContactDr Santhanakrishnan Ramakrishnan

SKS Hospital and Postgraduate Medical Institute

ramakrishnan.s@sksh.ac.in9655319192

Outcome results

None listed

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