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Automated adjustment of inspired oxygen in premature infants requiring mechanical ventilation

Efficacy of automated control of inspired oxygen in ventilated preterm infants: a randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN94119947
Enrollment
30
Registered
2015-03-23
Start date
2012-01-30
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Respiratory failure in preterm infants requiring mechanical ventilation Neonatal Diseases Respiratory failure of newborn

Interventions

This randomized crossover trial involved preterm infants who are mechanically ventilated and receiving supplemental oxygen. Each infant was studied for two consecutive 12-hour periods, one with inspir

Sponsors

South Tees Hospital NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Preterm infants were enrolled in the study if they met all of the following inclusion criteria: 1. Written informed parental consent 2. Receiving mechanical ventilation through an endotracheal tube 3. On supplemental oxygen at the time of enrolment and during the previous 24 hours 4. Without major congenital anomalies

Exclusion criteria

Exclusion criteria: 1. Major congenital anomalies 2. Not requiring supplemental oxygen during the previous 24 hours prior to enrollment.

Design outcomes

Primary

MeasureTime frame
Proportion of time with pulse oximetry (SpO2) within the assigned target range of 90-95% during two consecutive 12-hour periods of automated and manual adjustment of inspired oxygen (FiO2).

Secondary

MeasureTime frame
Proportion of time with pulse oximetry (SpO2) outside of the assigned target range of 90-95%, extreme hypoxemia (<80%) and hyperoxemia (=98%) during two consecutive 12-hour periods of automated and manual adjustment of inspired oxygen (FiO2).

Countries

United Kingdom

Contacts

Public ContactMithilesh Lal

Outcome results

None listed

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