Please proved a response to passage 1 and 2 .Peer replies should consist of critical analysis of the strengths and weaknesses posed by your peers.
The clinical trial I found compelling is titled The Budesonide in Babies (BIBs) Trial. This study builds on prior evidence from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network (NRN), which reported that 47% of extremely preterm infants (gestational age 22–28 weeks) who survived to 36 weeks postmenstrual age developed bronchopulmonary dysplasia (NICHD Neonatal Research Network, 2025). These findings highlight the urgent need for effective interventions in this high-risk population. The BIBs trial is investigating whether administering a combination of budesonide and Curosurf (a surfactant) could reduce the incidence of BPD or death compared to treatment with surfactant alone.
The BIBs trial is currently in phase III, indicating that the treatment has demonstrated an acceptable safety profile in phase I and preliminary effectiveness in phase II. In this phase, researchers are enrolling a larger group of participants to confirm the treatment’s efficacy, monitor for any side effects, and compare outcomes to those of existing therapies (Kandi & Vadakedath, 2023). The data gathered in this phase will play a key role in determining how effective the treatment is and whether it will be submitted for FDA approval.
The study is well structured. BIBs is a parallel, randomized, interventional, quadruple-masked, multicenter trial. Patients are randomly assigned to one of two arms in the study: the control group or the experimental group. The participant, primary care provider, investigator, and outcomes assessor are unaware of group assignments to eliminate bias. Only the research pharmacists and a designated respiratory therapist (or qualified person) are unmasked to allow mixing of the drugs at the bedside (NICHD Neonatal Research Network, 2025). The researchers set clearly defined inclusion and exclusion criteria appropriate for the trial. To gather data, 19 institutions are participating in this trial. Those institutions are University of Alabama (Alabama), Stanford University (California), Sharp Mary Birch Hospital for Women and Newborns (California), Emory University (Georgia), Northwestern Lurie Children’s Hospital of Chicago (Illinois), University of Iowa (Iowa), University of Mississippi Medical Center-Children’s of Mississippi (Mississippi), Univeristy of New Mexico (New Mexico), University of Rochester (NY), RTI International and Duke University (North Carolina), Cincinnati Children’s Medical Center (Ohio), Case Western Reserve University and Rainbow Babies and Children’s Hospital (Ohio), Research Institute at Nationwide Children’s Hospital (Ohio), University of Pennsylvania (Pennsylvania), Brown University Women and Infants Hospital of Rhode Island (Rhode Island), University of Texas Southwestern Medical Center at Dallas (Texas), University of Texas Health Science Center at Houston (Texas), and University of Utah (Utah) (NICHD Neonatal Research Network, 2025).
Up to this point, I could not identify any weaknesses in the study’s design. The Budesonide in Babies (BIBs) Trial represents an important development in addressing the high incidence of BPD among extremely preterm infants. Its thorough design, blinding strategy, and multi-institutional collaboration strengthen the validity and reliability of the results. If successful, this trial could offer a new standard of care that significantly improves outcomes for one of the most vulnerable neonatal populations.
References
Kandi, V., & Vadakedath, S. (2023). Clinical Trials and Clinical Research: A Comprehensive Review. Cureus, 15(2), e35077. https://doi.org/10.7759/cureus.35077 Links to an external site.
NICHD Neonatal Research Network. (2025, February 6). The Budesonide in Babies Trial (NCT04545866). Clinicaltrials.gov. https://clinicaltrials.gov/study/NCT04545866?cond=Bronchopulmonary+Dysplasia&aggFilters=status%3Aact&page=2&rank=12&a=12
2.
A Two Year Longitudinal Clinical Study of Neurocognitive and Psychiatric Symptoms in Post COVID-19 Patients Links to an external site.
The primary objective of this research performed in Sweden, is to advance knowledge of the biological mechanisms underlying COVID-19’s long-term effects. Specifically, it investigates how biomarkers relate to the severity of symptoms and assesses their potential as diagnostic indicators over a 24-month period.
The study follows up to 100 participants diagnosed with post-acute sequelae of SARS-CoV-2 infection (PASC) over a span of two years. Researchers track physical, psychological, and neurocognitive symptoms at three assessment points baseline, 12 months, and 24 months. They analyze correlations between these symptoms and biomarkers found in blood, cerebrospinal fluid, and fecal samples, as well as observe neuroradiological changes in MRI scans at baseline and 24 months (Freund-Levi, 2025).
Strengths of the Study
The study has several inherent strengths:
Longitudinal Design: The two-year follow-up period is a significant strength. Many early post-COVID studies were cross-sectional or had shorter follow-up durations. A longitudinal approach allows researchers to track changes over time, differentiate between transient and persistent symptoms, and potentially identify causative pathways and long-term outcomes (Freund-Levi, 2025).
Focus on Neurocognitive and Psychiatric Symptoms: These are among the most frequently reported and debilitating aspects of “Long COVID”
Potential for Comprehensive Data Collection: Longitudinal studies often allow for the collection of a wide range of data points at multiple intervals, including clinical assessments, patient-reported outcomes, and potentially biomarkers, which can provide a rich dataset for analysis (Carrasco-Ribelles & José Llanes-Jurado, 2023).
Contribution to a Critical Area of Need: Understanding and managing Long COVID is a global health priority. This study will contribute valuable data to the growing body of evidence on the long-term impacts of the virus.
Potential Weaknesses and Challenges:
Recruitment and Participant Retention: Ensuring a sufficiently large and representative sample is often difficult. Maintaining engagement over the two-year duration poses many challenges.
Defining Study Groups: A precise classification of “post-COVID-19 patients” is necessary, including factors such as illness severity, hospitalization history, and the time elapsed since infection. The inclusion or exclusion of a control group whether composed of uninfected individuals or those who had COVID-19 but did not experience long-term symptoms, impacts the reliability of findings.
Variables: Multiple external factors, such as pre-existing medical conditions, socioeconomic status, and pandemic-related stressors unrelated to infection, can affect neurocognitive and psychiatric health. Controlling for these variables statistically is both crucial and challenging.
Demand for Resources: Conducting a longitudinal study requires extensive time, financial investment, and sustained research infrastructure. Securing ongoing funding and institutional support is vital for the study’s success.
References
Carrasco-Ribelles, L. A., & José Llanes-Jurado. (2023). Prediction models using artificial intelligence and longitudinal data from electronic health records: a systematic methodological review. Journal of the American Medical Informatics Association, 30(12), 2072–2082. https://doi.org/10.1093/jamia/ocad168 Links to an external site.
Freund-Levi, Y. (2025, February 11). A Two Year Longitudinal Clinical Study of Neurocognitive and Psychiatric Symptoms in Post COVID-19 Patients (PASC24). Clinicaltrials.gov. https://clinicaltrials.gov/study/NCT06298006?term=respiratory%20care%20that%20is%20currently%20in%20progress&limit=25&sort=StudyFirstPostDate&viewType=Ca