Study Summary
This trial is a randomized controlled trial, which is the best way to determine if one treatment is better than the other.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 21 Secondary · Reporting Duration: 34 - 36 weeks post-menstrual age
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Primary Comparator
1 of 1
Active Control
240 Total Participants · 1 Treatment Group
Primary Treatment: Primary Comparator · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 7 - 32 · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Donovan, Jenny L., J. Athene Lane, Tim J. Peters, Lucy Brindle, Elizabeth Salter, David Gillatt, Philip Powell, Prasad Bollina, David E. Neal, and Freddie C. Hamdy. 2009. “Development of a Complex Intervention Improved Randomization and Informed Consent in a Randomized Controlled Trial”. Journal of Clinical Epidemiology. Elsevier BV. doi:10.1016/j.jclinepi.2008.02.010.
- Hamdy, Freddie C., Jenny L. Donovan, J. Athene Lane, Malcolm Mason, Chris Metcalfe, Peter Holding, Michael Davis, et al.. 2016. “10-year Outcomes After Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1606220.
- Jepson, Marcus, Daisy Elliott, Carmel Conefrey, Julia Wade, Leila Rooshenas, Caroline Wilson, David Beard, et al.. 2018. “An Observational Study Showed That Explaining Randomization Using Gambling-related Metaphors and Computer-agency Descriptions Impeded Randomized Clinical Trial Recruitment”. Journal of Clinical Epidemiology. Elsevier BV. doi:10.1016/j.jclinepi.2018.02.018.
- Glaser BG, Strauss AL. The Discovery of Grounded Theory: Strategies for Qualitative Research. Vol. ed.: Aldine; 1967.
- Donovan, Jenny L., Isabel de Salis, Merran Toerien, Sangeetha Paramasivan, Freddie C. Hamdy, and Jane M. Blazeby. 2014. “The Intellectual Challenges and Emotional Consequences of Equipoise Contributed to the Fragility of Recruitment in Six Randomized Controlled Trials”. Journal of Clinical Epidemiology. Elsevier BV. doi:10.1016/j.jclinepi.2014.03.010.
- Benitz, William E. 2011. “Patent Ductus Arteriosus: To Treat or Not to Treat?”. Archives of Disease in Childhood - Fetal and Neonatal Edition. BMJ. doi:10.1136/archdischild-2011-300381.
- Benitz, William E., Kristi L. Watterberg, Susan Aucott, James J. Cummings, Eric C. Eichenwald, Jay Goldsmith, Brenda B. Poindexter, et al.. 2016. “Patent Ductus Arteriosus in Preterm Infants”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2015-3730.
- Szklo M, Nieto FJ. Epidemiology: Beyond the Basics. Vol. 3rd ed. Burlington, MA: Jones & Bartlett Learning; 2014.
- Coyne, IT. 1997. “Sampling in Qualitative Research. Purposeful and Theoretical Sampling; Merging or Clear Boundaries?”. Journal of Advanced Nursing. Wiley. doi:10.1046/j.1365-2648.1997.t01-25-00999.x.
- Watterberg, Kristi L., Michele C. Walsh, Lei Li, Sanjay Chawla, Carl T. D’Angio, Ronald N. Goldberg, Susan R. Hintz, et al.. 2022. “Hydrocortisone to Improve Survival Without Bronchopulmonary Dysplasia”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2114897.
- Donovan, Jenny L., Leila Rooshenas, Marcus Jepson, Daisy Elliott, Julia Wade, Kerry Avery, Nicola Mills, Caroline Wilson, Sangeetha Paramasivan, and Jane M. Blazeby. 2016. “Optimising Recruitment and Informed Consent in Randomised Controlled Trials: The Development and Implementation of the Quintet Recruitment Intervention (QRI)”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-016-1391-4.
- Wilson, Caroline, Leila Rooshenas, Sangeetha Paramasivan, Daisy Elliott, Marcus Jepson, Sean Strong, Alison Birtle, et al.. 2018. “Development of a Framework to Improve the Process of Recruitment to Randomised Controlled Trials (rcts): The SEAR (screened, Eligible, Approached, Randomised) Framework”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-017-2413-6.
- Paramasivan, Sangeetha, Sean Strong, Caroline Wilson, Bruce Campbell, Jane M Blazeby, and Jenny L Donovan. 2015. “A Simple Technique to Identify Key Recruitment Issues in Randomised Controlled Trials: Q-QAT - Quanti-qualitative Appointment Timing”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-015-0617-1.
- Jensen, Erik A., Sara B. DeMauro, Michael Kornhauser, Zubair H. Aghai, Jay S. Greenspan, and Kevin C. Dysart. 2015. “Effects of Multiple Ventilation Courses and Duration of Mechanical Ventilation on Respiratory Outcomes in Extremely Low-birth-weight Infants”. JAMA Pediatrics. American Medical Association (AMA). doi:10.1001/jamapediatrics.2015.2401.
- Donovan, Jenny L, Sangeetha Paramasivan, Isabel de Salis, and Merran Toerien. 2014. “Clear Obstacles and Hidden Challenges: Understanding Recruiter Perspectives in Six Pragmatic Randomised Controlled Trials”. Trials. Springer Science and Business Media LLC. doi:10.1186/1745-6215-15-5.
- L. Orton, Jane, Jennifer L. McGinley, Lisa M. Fox, and Alicia Jane Spittle. 2015. “Challenges of Neurodevelopmental Follow-up for Extremely Preterm Infants at Two Years”. Early Human Development. Elsevier BV. doi:10.1016/j.earlhumdev.2015.09.012.
- Vliegenthart, Roos J S, Anton H van Kaam, Cornelieke S H Aarnoudse-Moens, Aleid G van Wassenaer, and Wes Onland. 2019. “Duration of Mechanical Ventilation and Neurodevelopment in Preterm Infants”. Archives of Disease in Childhood - Fetal and Neonatal Edition. BMJ. doi:10.1136/archdischild-2018-315993.
- Liebowitz, Melissa, Anup Katheria, Jason Sauberan, Jaideep Singh, Kelly Nelson, Denise C. Hassinger, Susan W. Aucott, et al.. 2019. “Lack of Equipoise in the PDA-TOLERATE Trial: A Comparison of Eligible Infants Enrolled in the Trial and Those Treated Outside the Trial”. The Journal of Pediatrics. Elsevier BV. doi:10.1016/j.jpeds.2019.05.049.
- Rooshenas, Leila, Lauren J. Scott, Jane M. Blazeby, Chris A. Rogers, Kate M. Tilling, Samantha Husbands, Carmel Conefrey, et al.. 2019. “The Quintet Recruitment Intervention Supported Five Randomized Trials to Recruit to Target: A Mixed-methods Evaluation”. Journal of Clinical Epidemiology. Elsevier BV. doi:10.1016/j.jclinepi.2018.10.004.
- Mills, Nicola, Jenny L. Donovan, Julia Wade, Freddie C. Hamdy, David E. Neal, and J. Athene Lane. 2011. “Exploring Treatment Preferences Facilitated Recruitment to Randomized Controlled Trials”. Journal of Clinical Epidemiology. Elsevier BV. doi:10.1016/j.jclinepi.2010.12.017.
- Berry, Donald A., and Larry M. Pearson. 1985. “Optimal Designs for Clinical Trials with Dichotomous Responses”. Statistics in Medicine. Wiley. doi:10.1002/sim.4780040410.
- Wasserstein RL, Schirm AL, Lazar NA. Moving to a world beyond "p
- Rooshenas, Leila, Sangeetha Paramasivan, Marcus Jepson, and Jenny L. Donovan. 2019. “Intensive Triangulation of Qualitative Research and Quantitative Data to Improve Recruitment to Randomized Trials: The Quintet Approach”. Qualitative Health Research. SAGE Publications. doi:10.1177/1049732319828693.
- Rooshenas, Leila, Daisy Elliott, Julia Wade, Marcus Jepson, Sangeetha Paramasivan, Sean Strong, Caroline Wilson, et al.. 2016. “Conveying Equipoise During Recruitment for Clinical Trials: Qualitative Synthesis of Clinicians’ Practices Across Six Randomised Controlled Trials”. Edited by Sanjay Basu. PLOS Medicine. Public Library of Science (PLoS). doi:10.1371/journal.pmed.1002147.
- US Food and Drug Administration. Use of electronic informed consent, questions and answers: Guidance for institutional review boards, investigators, and sponsors. Silver Spring, MD: US Food and Drug Administration. 2016.
- Gordon Lan KK, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika. 1983;70(3):659-663.
- Lawrence, Colleen E., Leah Dunkel, Mark McEver, Tiffany Israel, Robert Taylor, Germán Chiriboga, Karin Valentine Goins, et al.. 2020. “A Redcap-based Model for Electronic Consent (econsent): Moving Toward a More Personalized Consent”. Journal of Clinical and Translational Science. Cambridge University Press (CUP). doi:10.1017/cts.2020.30.
- Baron, Reuben M., and David A. Kenny. 1986. “The Moderator–mediator Variable Distinction in Social Psychological Research: Conceptual, Strategic, and Statistical Considerations.”. Journal of Personality and Social Psychology. American Psychological Association (APA). doi:10.1037/0022-3514.51.6.1173.
- Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986 Dec;51(6):1173-82. doi: 10.1037//0022-3514.51.6.1173.
- Coyne IT. Sampling in qualitative research. Purposeful and theoretical sampling; merging or clear boundaries? J Adv Nurs. 1997 Sep;26(3):623-30. doi: 10.1046/j.1365-2648.1997.t01-25-00999.x.
- Carl Backes, MD 2023. "Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05547165.
Frequently Asked Questions
Do you accept participants who are over fifty years of age for this examination?
"This research requires participants who are between 7 and 32 years of age." - Anonymous Online Contributor
Is there a possibility of my participation in this clinical trial?
"This study seeks to enrol 240 neonates between 7 and 32 days of age with a patent ductus arteriosus. To qualify, infants must have been born within the 22-week+0 day (220/7 weeks) through 27-weeks+6 day (276/7 weeks) gestational window; weigh at least 700 grams; be mechanically ventilated when consenting and randomizing; exhibit an ECHO score of 6 or greater on their HSPDA ("PDA Score"); and randomization must occur within 5 days postnatal from obtaining the qualifying ECHO." - Anonymous Online Contributor
Which Canadian health care centers have been assigned to this medical investigation?
"At present, 23 sites are permitting the enrollment of patients. These include Seattle, Sacramento and Ann Arbor along with 20 additional cities. To minimize travel costs associated with participation in this study it is advisable to enroll at a site near your residence." - Anonymous Online Contributor
Are there any vacant spots available for participants in this experiment?
"As per the information provided on clinicaltrials.gov, this medical research is not in need of participants at present time. Initially posted March 1st 2023 and last updated September 15th 2022, there are currently 14 other investigations recruiting volunteers." - Anonymous Online Contributor