Status:
NOT_YET_RECRUITING
MINImising Total Radiation EXposure in Preterm Infants
Lead Sponsor:
Western Health, Australia
Conditions:
Neonatal Respiratory Distress Syndrome
PreTerm Neonate
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE2
Brief Summary
Being born too early (preterm birth) is the leading cause of death in children world-wide. In Australia, 97% of very preterm babies who are admitted to Neonatal Intensive Care Units need breathing sup...
Detailed Description
Preterm babies are born with underdeveloped, fragile lungs and commonly develop respiratory distress syndrome. In Australia, 97% of preterm babies who are admitted to Neonatal Intensive Care Units nee...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- All infants born \<32 weeks' gestation and admitted to the neonatal intensive care unit (NICU) who require lung imaging for respiratory indications will be considered eligible. Each infant must meet all the following criteria to be enrolled in this study:
- The infant is born from 22 to 31+6 weeks' gestation by best obstetric estimate and admitted to the NICU
- The infant is considered to require lung imaging for respiratory indications
- The infant has a parent/guardian who can provide informed consent.
- Exclusion Criteria
- The infant will only require CXR to be performed solely to confirm device position i.e. central line, endotracheal tube, gastric tubes
- The infant will only require CXR to be performed for specifically for non-respiratory indications i.e. assessment of cardiac silhouette
- The infant's Clinician has concern regarding clinical stability and tolerability of ultrasound scans
- The infant's skin integrity will not tolerate ultrasound gel
- Refusal of informed consent by their parent/guardian/legally acceptable representative
- The infant does not have a parent/guardian who can provide informed consent.
Exclusion
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06975189
Start Date
August 1 2025
End Date
December 1 2028
Last Update
July 2 2025
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