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Predictive Value of Bedside Lung Ultrasound in Preterm Infants with Respiratory Distress and the Evolution of Bronchopulmonary Dysplasia

Predictive Value of Bedside Lung Ultrasound in Preterm Infants with Respiratory Distress and the Evolution of Bronchopulmonary Dysplasia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12617000208303
Enrollment
45
Registered
2017-02-08
Start date
2017-04-10
Completion date
Unknown
Last updated
2018-01-24

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

Conditions

None listed

Brief summary

Lung ultrasound is widely used within adult critical care with international evidence based recommendations for its utility in the assessment of patients with respiratory compromise. Further research is required to validate its clinical application within neonatal intensive care. Lung ultrasound is an attractive bedside clinical tool that is simple, non-invasive, quick to perform and well tolerated by even the most preterm of babies, using ultrasound equipment already in routine use. Bronchopulmonary dysplasia (BPD) is a process that starts soon after birth in preterm infants, with scarring and inflammatory changes within the lungs that may be slow to appear on conventional chest x-ray. Lung ultrasound performed in the first week of life may be more sensitive in recognising these changes earlier with the potential to assist in prediction of BPD and better direct therapeutic interventions (Raimondi et al 2014). A prospective observational cohort study will be undertaken performing lung ultrasound in 100 preterm infants born <28 weeks’ gestation admitted to KEMH neonatal intensive care unit receiving respiratory support. The study aims to determine if lung ultrasound can predict the development of BPD and respiratory outcomes.

Interventions

Diagnostic assessment: Serial bedside lung ultrasounds will be performed on three occasions in the first week of life (day 1, day 3-4, day 7), day 28 and between 35 weeks +0 days to 36 weeks +6 days postmenstrual age. Ultrasounds will be performed in conjunction with clinician performed bedside cardiac or cranial ultrasound assessments as part of routine care or coinciding with PIFCO assessment on day 7 if enrolled (Preterm Infant Functional and Clinical Outcome (PIFCO) Study: 2013091E/W) and th

Diagnostic assessment: Serial bedside lung ultrasounds will be performed on three occasions in the first week of life (day 1, day 3-4, day 7), day 28 and between 35 weeks +0 days to 36 weeks +6 days postmenstrual age. Ultrasounds will be performed in conjunction with clinician performed bedside cardiac or cranial ultrasound assessments as part of routine care or coinciding with PIFCO assessment on day 7 if enrolled (Preterm Infant Functional and Clinical Outcome (PIFCO) Study: 2013091E/W) and the scheduled ANZNN Shift Test. Lung Ultrasound Protocol Bedside ultrasound examinations are to be performed with the infant nursed in a supine position on radiant warmer or incubator, with continuous cardiovascular and respiratory monitoring in situ. Measures will be employed to optimise thermal care and patient comfort during the procedure such as pre-warmed jelly and a sterile NeoWrap sheet placed over infant. The duration of any lung ultrasound examination will be limited to a maximum of 5 minutes to avoid patient discomfort and minimise excessive handling. Philips iE33 ultrasound machine in current use for clinician performed ultrasounds in KEMH NICU, utilising a high resolution 11-3 MHz linear probe with dedicated lung pre-set, focus point at pleural line, depth 2.5 cm, duration of video loops lasting 6 seconds encompassing full respiratory cycles. All will be acquired in a standardised sequence. The project will include development of an interactive training module and assessment to standardise the way lung ultrasounds are performed. We will also generate a scoring system from the first 50 patients to develop a predictive statistical model for the development of BPD to be applied to a further 50 recruited patients.

Sponsors

Neonatal Clinical Care Unit
Lead SponsorHospital

Eligibility

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

Inclusion criteria

1) Preterm infants born less than 28 completed weeks gestation; 2) Admission to the KEMH NICU within 24 hours of birth; 2) Requirement for any modality of respiratory support; 4) Informed parental assent to undertake ultrasounds in NICU in conjunction with scheduled examinations. Given the practical difficulties in obtaining written parental consent within 24 hours of birth in an extremely preterm infant, and mindful approach to limiting parental stress and avoidance of excessive burden of information, ultrasound images will only be included in this study and analysed if parental consent is obtained at the earliest possibility prior to day 3.

Exclusion criteria

Outborn infants birthed in a non-tertiary institution subsequently transferred to KEMH NICU will be excluded from the study given lower rates of complete antenatal steroid coverage and optimal conditions for resuscitation, early stabilisation and documented poorer outcomes. Exclusion will also apply to major congenital abnormalities affecting the thoracic organs, or control of breathing.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 15, 2026