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Non-invasive assessment of pulmonary shunt and ventilation-perfusion status in newborn infants during minimally invasive surfactant therapy

Non-invasive assessment of pulmonary shunt and ventilation-perfusion status in newborn infants during minimally invasive surfactant therapy

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619000313134
Enrollment
50
Registered
2019-02-28
Start date
2019-03-01
Completion date
2020-03-01
Last updated
2019-07-15

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

Conditions

None listed

Brief summary

We aim to utilise a novel method for non-invasively estimating the ventilation-perfusion mismatch, a measure of the severity of lung disease of preterm babies with respiratory distress syndrome. The Lockwood algorithm uses routinely measure oxygen saturation levels paired with the amount of oxygen needed in order to calculate how much the oxygen dissociation curve has been "shifted" to provide a measure of the right-left shunt. This study aims to use measures of oxygen levels before and after surfactant treatment and the corresponding ventilation-perfusion levels in order to gauge response of the infant's lungs to surfactant treatment. The hypothesis is that the Lockwood measure will provide robust measure of ventilation-perfusion status in preterm infants with respiratory distress,

Interventions

Concentration of inspired oxygen (FiO2). The amount of inspired oxygen (FiO2) that preterm infant needs to maintain oxygen within target range oxygen saturation (SpO2) of 91-95%, before and after surfactant administration. Before surfactant administration, this will be noted from observation of clinically needed interventions by nurses or doctors caring for the infant. The aim will be to record a minimum of 3 FiO2/SpO2 pairs. If these pairs are not available from clinically indicated change, th

Concentration of inspired oxygen (FiO2). The amount of inspired oxygen (FiO2) that preterm infant needs to maintain oxygen within target range oxygen saturation (SpO2) of 91-95%, before and after surfactant administration. Before surfactant administration, this will be noted from observation of clinically needed interventions by nurses or doctors caring for the infant. The aim will be to record a minimum of 3 FiO2/SpO2 pairs. If these pairs are not available from clinically indicated change, then FiO2 will be varied in small increments/decrements (of 1-2%) while ensuring is still within target range, i.e. intended SpO2 levels will always be within clinically indicated range, then returning this to the original FiO2 level. The aim will be to have at least 3 pairs of FiO2/SpO2 pairs overall. This observation will be repeated in the epoch post surfactant administration via minimally invasive surfactant therapy (MIST).

Sponsors

Monash Newborn
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
No minimum to 3 Days
Healthy volunteers
No

Inclusion criteria

Preterm infants receiving minimally invasive surfactant therapy (MIST) while treated with non-invasive respiratory support Infants (born <36+6 weeks gestation) Diagnosis of Respiratory Distress Syndrome (RDS)

Exclusion criteria

Infant intubated for surfactant therapy Major congenital anomalies Infants who are very ill and unstable

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026