Bronchopulmonary Dysplasia Prevention Study Consent Form

Bronchopulmonary Dysplasia Prevention Study: Research Participation & Consent

Conducting clinical research on extremely preterm infants requires meticulous informed consent processes and careful data collection. This Bronchopulmonary Dysplasia (BPD) Prevention Study Consent Form is designed specifically for neonatal research teams, hospitals, and academic medical centers conducting trials on respiratory interventions for premature babies.

Why This Template Works for Neonatal Research

This form streamlines the complex process of enrolling extremely preterm infants (born before 28 weeks gestation) into BPD prevention studies. It guides parents and legal guardians through detailed study information, intervention protocols including surfactant administration and ventilation strategies, potential risks and benefits, and comprehensive consent documentation.

The template is built for neonatologists, clinical research coordinators, NICU teams, and pediatric researchers who need to meet stringent IRB requirements while maintaining compassionate, clear communication with families during a highly stressful time.

Integrated Workflows for Clinical Research

Using Paperform's conditional logic, this form adapts based on gestational age, birth weight, and specific study arm randomization. When integrated with Stepper, you can automate critical research workflows: trigger notifications to the research team when consent is obtained, update REDCap or other clinical trial databases automatically, schedule follow-up assessments, and maintain HIPAA-compliant audit trails.

For studies requiring formal consent signatures, Papersign enables secure electronic signatures from both parents/guardians and witnessing staff members, creating legally binding consent documents that remain linked to the original enrollment data.

Designed for Regulatory Compliance

This template addresses the unique regulatory requirements of neonatal clinical trials, including detailed disclosure of experimental interventions, randomization procedures, data privacy protections, and withdrawal rights. The clear, accessible language helps research teams meet Good Clinical Practice (GCP) standards while ensuring families truly understand what study participation means for their vulnerable infant.

Whether you're conducting single-center pilots or multi-site randomized controlled trials, this form provides the foundation for ethical, compliant, and efficient participant enrollment in critical neonatal respiratory research.