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CUMULUS: Comparing Ultrasound Markers of Under recruited Lung in preterm infants on respiratory Support

Comparing an ultrasound derived lung aeration score to radiological diagnosis of underinflation and respiratory support requirements in preterm infants.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621001119886
Acronym
CUMULUS
Enrollment
70
Registered
2021-08-23
Start date
2020-09-29
Completion date
2022-06-03
Last updated
2023-07-18

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

Conditions

None listed

Brief summary

Preterm infants frequently require mechanical ventilation. This lifesaving intervention is associated with long term respiratory consequences, the most important being bronchopulmonary dysplasia. To minimise this risk, clinicians employ lung protective ventilation strategies. Such strategies require detailed knowledge of the lung volume state. Lung volume is commonly assessed by chest x-rays (CXR). CXRs have disadvantages including not always being readily available, exposure to ionising radiation and only providing a static picture of lung, often at an uncertain point of the respiratory cycle. Lung ultrasound (LUS) is being increasingly utilised in neonatal intensive care units. It has proven utility in the diagnosis of respiratory distress syndrome (RDS), pneumothorax, consolidation and the need for surfactant and mechanical ventilation. Lung ultrasonography offers advantages over conventional imaging modalities: no ionising radiation, less manipulation of the patient and dynamic assessment of the lung. The precision and accuracy of this technique is to detect poor lung recruitment, and it’s correlation with respiratory support requirements in preterm infants warrants further exploration. We designed a prospective observational study to explore these applications. The results of this pilot study will support further clinical studies exploring the utility of LUS in guiding neonatal respiratory support.

Interventions

Preterm infants born < 32 weeks gestation and > 24 hours of age who are receiving a chest radiograph for any indication will receive a lung ultrasound immediately before the chest radiograph. Images of the anterior and lateral lung regions will be obtained for every infant. If positioned prone prior to the chest radiograph, posterior images will also be required. Ultrasound scans will take approximately 10 minutes. Ultrasound images will be obtained using a GE Venue 50 (GE, USA) or Philips Epiq

Preterm infants born < 32 weeks gestation and > 24 hours of age who are receiving a chest radiograph for any indication will receive a lung ultrasound immediately before the chest radiograph. Images of the anterior and lateral lung regions will be obtained for every infant. If positioned prone prior to the chest radiograph, posterior images will also be required. Ultrasound scans will take approximately 10 minutes. Ultrasound images will be obtained using a GE Venue 50 (GE, USA) or Philips Epiq 7 (Koninklijke Philips, Netherlands) ultrasound machine and a “hockey stick,” L8-18i linear transducer set at a depth of 2cm and a gain of 60. Six second video loops will be recorded. Lung ultrasounds will be blindly reported using a previously validated lung ultrasound scoring system. Chest radiographs will be blindly reported by a Paediatric Radiologist. Oxygen saturation index (OSI) will be determined at the time of the ultrasound scan. This measure is derived from the respiratory support settings and measured oxygen saturations. This does not involve extra handling for the infants.

Sponsors

The Royal Women's Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
24 Hours to No maximum
Healthy volunteers
No

Inclusion criteria

Very preterm infants born <32 weeks gestation and greater than 24 hours of age who require a chest radiograph

Exclusion criteria

• Congenital lung malformations including congenital diaphragmatic hernia • Major congenital cardiac defects • Known pleural effusions or pneumothorax • Respiratory distress syndrome where decisions about surfactant therapy are being made

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 11, 2026