Multidimensional Phenotype Classification in Grade 3 Bronchopulmonary Dysplasia

Launched by CHILDREN'S HOSPITAL OF PHILADELPHIA · Jun 20, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on understanding a serious condition called Bronchopulmonary Dysplasia (BPD), which often affects premature babies. Specifically, it aims to create a classification system for the most severe form of BPD, known as grade 3 BPD, where infants need help with breathing even after several weeks after their expected due date. Researchers will collect and analyze a wide range of health data to see how different characteristics of the condition relate to the babies' breathing and development as they grow, up to two years of age.

To participate in this study, infants must be born before 32 weeks of pregnancy and need breathing support at the time they join the trial. Parents or guardians will also be involved and must provide consent for their child to participate. Throughout the study, families can expect regular check-ups and detailed assessments to track the infant's health and progress. This research is important because it may help improve understanding and treatment of BPD, ultimately benefiting affected children and their families.

Gender

ALL

Eligibility criteria

• Inclusion Criteria (infant subjects):
• • Male or female infant born with gestational age \<32 weeks
• • Postmenstrual age between 36-65 weeks at enrollment
• • Receiving invasive ventilation at enrollment
• • Grade 3 BPD or grade 2 BPD with need for chronic invasive ventilation at enrollment
• • Parental informed consent (provides the consent to participate)
• Exclusion Criteria (infant subjects):
• • Contraindication to 1 or more of the study diagnostic procedures
• • Family unable/unlikely to commit to 2-year follow-up
• • Unlikely to survive the 6-8-week diagnostic period
• • Parental consent not provided (decline consenting for study)
• • Aneuploidy or other severe congenital abnormality not-representative in BPD
• At the time of consent, a parent or guardian caregiver will be invited to participate as an enrolled dyad using the following eligibility criteria:
• Inclusion criteria (parents/guardians):
• • Parent or legal guardian of an enrolled infant subject
• • Informed consent
• Exclusion criteria (parents/guardians):
• • Unable/unlikely to complete study procedures