RecruitingACTRN12624000851561

BLUEPRINT: Predicting Long-term Outcomes of Prematurity from Early Life Events

Predicting Long-term Outcomes of Prematurity from Early Life Events

Sponsor

Murdoch Children's Research Institute

Enrollment

550 participants

Start Date

Jan 16, 2025

Study Type

Observational

Conditions

Chronic Lung Disease of Infancy Respiratory Disease Prematurity

Summary

Most babies born preterm have breathing problems shortly after birth, and many need help with their breathing. Clinicians have many treatments to help preterm babies breath, and know which treatments works best for most babies. But clinicians don’t know which treatments will work best for each baby. The BLUEPRINT Study aims to provide a more precise picture (phenotype) of how a specific preterm baby’s lungs are working in the first 7 days after birth. This will be achieved by combining information on the clinical care being used, measurements of lung function and the pattern of proteins in the blood collected 3 and 7 days after birth. We will then follow babies through until 2 years of age to measure their lung growth and function. By understanding the different lung phenotypes that exist in preterm babies, we hope to help doctors know which treatments may be best for a baby and predict which baby might be at more risk for lung problems as they grow up.

Eligibility

Sex: Both males and femalesMin Age: 0 HourssMax Age: 72 Hourss

Plain Language Summary

Simplified for easier understanding

Premature babies — especially those born before 32 weeks — almost always need help breathing after birth, and doctors have many tools available to support them. However, what works best for one baby may not work best for another, and it can be hard to predict in advance which approach is right for a specific infant. The BLUEPRINT Study aims to create a more precise picture of how individual preterm babies' lungs are functioning in the first week of life by combining clinical information with measurements of lung function and protein patterns in the blood. Babies will then be followed until age two to see how their lung development progresses. The goal is to help doctors identify which babies might benefit from different treatments and predict those at higher risk of long-term lung problems. Your baby may be eligible if they are born between 22 and 31 weeks and 6 days of gestation at a participating Victorian NICU. Consent must be obtained before birth or within 72 hours of delivery. Babies with major congenital anomalies or cardiac conditions would not be eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The BLUEPRINT Study is a prospective longitudinal observational cohort study using clinical, lung imaging and plasma protein data to define the early postnatal respiratory endotypes following preterm

The BLUEPRINT Study is a prospective longitudinal observational cohort study using clinical, lung imaging and plasma protein data to define the early postnatal respiratory endotypes following preterm birth, and to determine the relationship with bronchopulmonary dysplasia (BPD) and 1- and 2-year respiratory outcomes. The primary objective of the BLUEPRINT Study is to comprehensively define respiratory endotypes in the first 7 days after birth in preterm infants born between 22 and 32 weeks’ inclusive gestation. The secondary objectives include: 1) To develop the first functional classification of preterm respiratory disease using a combination of clinical, lung imaging and molecular biomarkers, 2) To delineate how specific early preterm phenotypes relate to a diagnosis of BPD and develop a predictive modelling tool for early diagnosis, and 3) To characterise the respiratory and general health of preterm infants in the first 2 years corrected age. Infants born between 22+0 and 31+6 weeks’ gestation admitted to a participating centre from whom parental informed consent can be obtained will be considered eligible. Eligible and enrolled infants will have clinical data relating to their antenatal, maternal and postnatal respiratory and neonatal intensive care course collected at pre-defined time points between birth and neonatal intensive care unit (NICU) discharge. In addition, a maximum of 0.5 ml of blood will be collected at 72 hours and 7 days for analysis of lung-specific proteins in the plasma using proteomics, and a brief lung ultrasound (LUS) and electrical impedance tomography (EIT) image of the lung performed at 48 and 72 hours, 7, 14 and 28 days, and then at 36 weeks’ corrected gestational age (BPD diagnosis). LUS, EIT and plasma proteomic analysis are not considered standard of care in the NICU and will only be performed in infants participating in the BLUEPRINT study, however these measurements will not be altering clinical care or clinical course of the participating infant. Lung imaging and assessment of respiratory health using standardised parental questionnaires will be repeated at 1 and 2 years corrected age in preterm survivors. The parental questionnaires include: PARCA-R questionnaire of developmental status (approximately 30 min to complete) General Infant Respiratory and Health questionnaire (approximately 10-15 min to complete) 550 infants will be studied from all Level 6 Neonatal Intensive Care Units in Victoria. Recruitment and follow up is anticipated to be finished in approximately 5 years.