Pilot Feasibility Stud. 2025 Dec 2. doi: 10.1186/s40814-025-01740-3. Online ahead of print.
ABSTRACT
BACKGROUND: Bronchopulmonary dysplasia (BPD) is a common morbidity affecting preterm infants’ underdeveloped lungs, leading to long-term growth and neurodevelopmental issues. Despite its significance, no clinical prediction model exists for neonatologists.
AIM: To assess the feasibility of study procedures and provide descriptive data to guide a large multicentre study for developing a BPD-prediction model.
METHODS: This was a single-centre feasibility observational cohort study conducted at a neonatal intensive care unit. Forty preterm infants born before 32 weeks of gestation were recruited within 18 months. Two echocardiographic scans on days 5 and 9 after birth were planned for each infant. Feasibility targets included achieving adequate recruitment and retention, ensuring at least 80% of recruited infants underwent two scans, and maintaining high-quality imaging, with at least 80% of scans analysable, particularly Tissue Doppler Imaging (TDI) and speckle tracking imaging (STI). Descriptive statistics for feasibility, demographic, clinical, and cardiac parameters of preterm infants with and without BPD are reported.
RESULTS: Seventy-seven preterm infants were screened for eligibility between June 2022 and May 2023. The target of 40 preterm infants was achieved within 11 months. All infants had the first echo scan performed, whereas 39 (97%) had a second one performed. Majority had their echo scans performed within 24 h of the prespecified timeframe, i.e. days 5 and 9 after birth (34 (85%) of the first and 28 (69%) of the second echo scans). All the first and 39 (97%) of the second echo scans, excluding STI, were suitable for analysing the cardiac parameters. Regarding STI, 38 (95%) of the first and 34 (85%) of the second echo scans were analysable. Compared with the 27 infants without BPD, the 13 BPD-affected preterm infants had a lower gestational age (median 26 vs 30 weeks) and lower birth weight (median 1370 vs 763 g). Clinically, respiratory support was greater in the BPD group than in the non-BPD group (median 8.3 vs 3.0 for the first scan; 7.9 vs 0.0 (cmH2O or L/min) for the second echo scan).
CONCLUSION: Our findings demonstrate that a large multicentre study is feasible and will inform the construction of a BPD-prediction model.
TRIAL REGISTRATION: NCT05235399.
PMID:41331480 | DOI:10.1186/s40814-025-01740-3
