POPS or POP02: Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

• Sponsor: Duke University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04278404
• Collaborator: The Emmes Company, LLC (Industry), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 5,000
• Locations: 49
• Anticipated Duration (Months): 49.6
• Patients Per Site: 102
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Infection (COVID-19); Pulmonary Arterial Hypertension; Urinary Tract Infections in Children; Hypertension; Pain; Hyperphosphatemia; Primary Hyperaldosteronism; Edema; Hypokalemia; Heart Failure; Hemophilia; Menorrhagia; Insomnia; Pneumonia; Skin Infection; Arrythmia; Asthma in Children; Bronchopulmonary Dysplasia; Adrenal Insufficiency; Fibrinolysis; Hemorrhage; Attention Deficit Hyperactivity Disorder; Multisystem Inflammatory Syndrome in Children (MIS-C); Kawasaki Disease; Coagulation Disorder; Down Syndrome	Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:

Study Design

• Study Type: Observational
• Anticipated Enrollment: 5000 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs
• Actual Study Start Date: Mar 5, 2020
• Anticipated Primary Completion Date: Apr 24, 2024
• Anticipated Study Completion Date: Apr 24, 2024

Arms and Interventions

Arm

Intervention/Treatment

Children and young adults who are prescribed drugs of interest Children and young adults who are prescribed drugs of interest as part of their routine medical care OR are SARS-CoV-2 positive.

Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care: The prescribing of drugs to children is not part of this protocol. Participants will receive DOIs as prescribed by their treating provider.; Other Names: Aminocaproic acid Amiodarone Bosentan Budesonide Cefdinir Cefepime Ceftazidime Clindamycin Clobazam Dexamethasone Dexmedetomidine Dextroamphetamine/Amphetamine Fosfomycin Furosemide Gabapentin Guanfacine Hydrocortisone Labetalol Meropenem Metformin Milrinone Nalbuphine Nicardipine Nifedipine Oseltamivir Oxycodone Risperidone Sertraline Sevelamer Carbonate / Sevelamer Hydrochloride Spironolactone Terbutaline Tranexamic acid Voriconazole Zolpidem Azithromycin Lopinavir/Ritonavir Ribavirin Tocilizumab Anakinra Aspirin Canakinumab Colchicine Interferon Remdesivir Ruxolitinib Sarilumab

Outcome Measures

Primary Outcome Measures

1. Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling [Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.]

2. Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling [Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.]

3. Elimination rate constant (ke) as measured by PK sampling [Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.]

4. Half-life (t1/2) as measured by PK sampling [Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.]

5. Absorption rate constant (ka) as measured by PK sampling [Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.]

6. AUC (area under the curve) as measured by PK sampling [Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.]

7. Maximum concentration (Cmax) as measured by PK sampling [Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.]

8. Time to achieve maximum concentration (Tmax) as measured by PK sampling [Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years to 20 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Participant is < 21 years of age

2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:

3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment

Exclusion Criteria:

1. Participant has a known pregnancy Below exclusion criteria apply only to participants receiving one or more of the study drugs of interest at the time of enrollment,

2. Has had intermittent dialysis within previous 24 hours

3. Has had a kidney transplant within previous 30 days

4. Has had a liver transplant within previous 1 year

5. Has had a stem cell transplant within previous 1 year

6. Has had therapeutic hypothermia within previous 24 hours

7. Has had plasmapheresis within the previous 24 hours

8. Has a Ventricular Assist Device

9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phoenix Children's Hospital	Phoenix	Arizona	United States	85016
2	Arkansas Children's Hospital Research Institute	Little Rock	Arkansas	United States	72202
3	University of California	Los Angeles	California	United States	90095
4	Colorado University Denver	Aurora	Colorado	United States	80045
5	Alfred I. DuPont Hospital for Children	Wilmington	Delaware	United States	19803
6	University of Florida Jacksonville Shands Medical Center	Jacksonville	Florida	United States	32209
7	Kapiolani Womens and Childrens Medical Center	Honolulu	Hawaii	United States	96826
8	Ann and Robert H. Lurie Childrens Hospital of Chicago	Chicago	Illinois	United States	60614
9	Riley Hospital for Children at Indiana University	Indianapolis	Indiana	United States	46202
10	University of Iowa Stead Family Children's Hospital	Iowa City	Iowa	United States	52242
11	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
12	Wesley Medical Center	Wichita	Kansas	United States	67214
13	University of Louisville Norton Childrens Hospital	Louisville	Kentucky	United States	40202
14	Tulane Pediatrics	New Orleans	Louisiana	United States	70001
15	Ochsner Baptist Clinical Trials Unit	New Orleans	Louisiana	United States	70115
16	Boston Children's Hospital	Boston	Massachusetts	United States	02115
17	Massachusetts General Hospital	Lexington	Massachusetts	United States	02421
18	University of Minnesota	Minneapolis	Minnesota	United States	55455
19	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
20	Mississippi Center for Advanced Medicine	Madison	Mississippi	United States	39110
21	Children's Mercy Hospital	Kansas City	Missouri	United States	64108
22	Childrens Mercy Hospital	Kansas City	Missouri	United States	64111
23	University of Nebraska Medical Center	Omaha	Nebraska	United States	68114
24	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
25	University of New Mexico Health Science Center	Albuquerque	New Mexico	United States	87131
26	Kravis Children's Hospital at Mt. Sinai	New York	New York	United States	10029
27	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599
28	Duke University Health System	Durham	North Carolina	United States	27710
29	East Carolina University	Greenville	North Carolina	United States	27834
30	New Hanover Regional Medical Center	Wilmington	North Carolina	United States	28401
31	Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio	United States	45229
32	Board of Regents of the University of Oklahoma	Oklahoma City	Oklahoma	United States	73104
33	Oregon Health and Science University	Portland	Oregon	United States	97239
34	Pennsylvania State University--Hershey Children's Hospital	Hershey	Pennsylvania	United States	17033
35	Rhode Island Hospital	Providence	Rhode Island	United States	02903
36	Medical University of South Carolina Children's Hospital	Charleston	South Carolina	United States	29425
37	University of South Carolina	Columbia	South Carolina	United States	29203
38	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee	United States	37232
39	Dell Children's Medical Center of Central Texas	Austin	Texas	United States	78723
40	University of Texas-Southwestern Medical Center	Dallas	Texas	United States	75390
41	University of Texas--Memorial Hermann Texas Medical Center	Houston	Texas	United States	77030
42	Seattle Children's Hospital	Seattle	Washington	United States	98105
43	University of Wisconsin	Madison	Wisconsin	United States	53705
44	University of Wisconsin	Madison	Wisconsin	United States	53705
45	University Wisconsin	Madison	Wisconsin	United States	53705
46	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
47	Children's Hospital of Eastern Ontario	Ottawa	Ontario	Canada
48	The Hospital for Sick Children	Toronto	Ontario	Canada
49	CHU Sainte-Justine	Montréal	Quebec	Canada

Sponsors and Collaborators

• Duke University
• The Emmes Company, LLC
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Principal Investigator: Chi Hornik, Duke Clinical Research Institute

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Food and Drug Administration. General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products
• Extracorporeal Life Support Organization (ELSO). ECLS Registry Report: International Summary Ann Arbor, MI: Extracorporeal Life Support Organization (ELSO); 2020
• Wildschut E, editor. Drug therapies in neonates and children during extracorporeal membrane oxygenation (ECMO); Keep your eyes open. Rotterdam, The Netherlands: Erasmus MC; 2010.

Publications

• Autmizguine J, Melloni C, Hornik CP, Dallefeld S, Harper B, Yogev R, Sullivan JE, Atz AM, Al-Uzri A, Mendley S, Poindexter B, Mitchell J, Lewandowski A, Delmore P, Cohen-Wolkowiez M, Gonzalez D; the Pediatric Trials Network Steering Committee. Population Pharmacokinetics of Trimethoprim-Sulfamethoxazole in Infants and Children. Antimicrob Agents Chemother. 2017 Dec 21;62(1). pii: e01813-17. doi: 10.1128/AAC.01813-17. Print 2018 Jan.
• Benjamin DK Jr, Smith PB, Murphy MD, Roberts R, Mathis L, Avant D, Califf RM, Li JS. Peer-reviewed publication of clinical trials completed for pediatric exclusivity. JAMA. 2006 Sep 13;296(10):1266-73.
• Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther. 2001 Mar;69(3):89-95. Review.
• Blatt J, Albo V, Prin W, Orlando S, Wollman M. Excessive chemotherapy-related myelotoxicity in children with Down syndrome and acute lymphoblastic leukaemia. Lancet. 1986 Oct 18;2(8512):914.
• Buck ML. Pharmacokinetic changes during extracorporeal membrane oxygenation: implications for drug therapy of neonates. Clin Pharmacokinet. 2003;42(5):403-17. Review.
• Capparelli E, Hochwald C, Rasmussen M, Parham A, Bradley J, Moya F. Population pharmacokinetics of cefepime in the neonate. Antimicrob Agents Chemother. 2005 Jul;49(7):2760-6.
• Centers for Disease Control and Prevention (CDC). Improved national prevalence estimates for 18 selected major birth defects--United States, 1999-2001. MMWR Morb Mortal Wkly Rep. 2006 Jan 6;54(51):1301-5.
• Cohen-Wolkowiez M, Benjamin DK Jr, Ross A, James LP, Sullivan JE, Walsh MC, Zadell A, Newman N, White NR, Kashuba AD, Ouellet D. Population pharmacokinetics of piperacillin using scavenged samples from preterm infants. Ther Drug Monit. 2012 Jun;34(3):312-9. doi: 10.1097/FTD.0b013e3182587665.
• Cohen-Wolkowiez M, Ouellet D, Smith PB, James LP, Ross A, Sullivan JE, Walsh MC, Zadell A, Newman N, White NR, Kashuba AD, Benjamin DK Jr. Population pharmacokinetics of metronidazole evaluated using scavenged samples from preterm infants. Antimicrob Agents Chemother. 2012 Apr;56(4):1828-37. doi: 10.1128/AAC.06071-11. Epub 2012 Jan 17.
• Dallefeld SH, Atz AM, Yogev R, Sullivan JE, Al-Uzri A, Mendley SR, Laughon M, Hornik CP, Melloni C, Harper B, Lewandowski A, Mitchell J, Wu H, Green TP, Cohen-Wolkowiez M. A pharmacokinetic model for amiodarone in infants developed from an opportunistic sampling trial and published literature data. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):419-430. doi: 10.1007/s10928-018-9576-y. Epub 2018 Feb 12.
• de Hoog M, Schoemaker RC, Mouton JW, van den Anker JN. Vancomycin population pharmacokinetics in neonates. Clin Pharmacol Ther. 2000 Apr;67(4):360-7.
• Drolet BA, Boakye-Agyeman F, Harper B, Holland K, Lewandowski A, Stefanko N, Melloni C; Pediatric Trials Network Steering Committee (See Acknowledgments for a listing of committee members.). Systemic timolol exposure following topical application to infantile hemangiomas. J Am Acad Dermatol. 2020 Mar;82(3):733-736. doi: 10.1016/j.jaad.2019.02.029. Epub 2019 Feb 18.
• European Union. Ethical considerations for clinical trials on medicinal products conducted with the paediatric population. Eur J Health Law. 2008 Jul;15(2):223-50.
• Foley CM, Deely DA, MacDermott EJ, Killeen OG. Arthropathy of Down syndrome: an under-diagnosed inflammatory joint disease that warrants a name change. RMD Open. 2019 Jun 3;5(1):e000890. doi: 10.1136/rmdopen-2018-000890. eCollection 2019.
• García B, Barcia E, Pérez F, Molina IT. Population pharmacokinetics of gentamicin in premature newborns. J Antimicrob Chemother. 2006 Aug;58(2):372-9. Epub 2006 Jun 16.
• Garré ML, Relling MV, Kalwinsky D, Dodge R, Crom WR, Abromowitch M, Pui CH, Evans WE. Pharmacokinetics and toxicity of methotrexate in children with Down syndrome and acute lymphocytic leukemia. J Pediatr. 1987 Oct;111(4):606-12.
• Goldstein SL, Nolin TD. Lack of drug dosing guidelines for critically ill patients receiving continuous renal replacement therapy. Clin Pharmacol Ther. 2014 Aug;96(2):159-61. doi: 10.1038/clpt.2014.102. Epub 2014 May 8. Review.
• Gonzalez D, Delmore P, Bloom BT, Cotten CM, Poindexter BB, McGowan E, Shattuck K, Bradford KK, Smith PB, Cohen-Wolkowiez M, Morris M, Yin W, Benjamin DK Jr, Laughon MM. Clindamycin Pharmacokinetics and Safety in Preterm and Term Infants. Antimicrob Agents Chemother. 2016 Apr 22;60(5):2888-94. doi: 10.1128/AAC.03086-15. Print 2016 May.
• Gonzalez D, Melloni C, Poindexter BB, Yogev R, Atz AM, Sullivan JE, Mendley SR, Delmore P, Delinsky A, Zimmerman K, Lewandowski A, Harper B, Lewis KC, Benjamin DK Jr, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act--Pediatric Trials Network Administrative Core Committee. Simultaneous determination of trimethoprim and sulfamethoxazole in dried plasma and urine spots. Bioanalysis. 2015;7(9):1137-49. doi: 10.4155/bio.15.38.
• Gonzalez D, Melloni C, Yogev R, Poindexter BB, Mendley SR, Delmore P, Sullivan JE, Autmizguine J, Lewandowski A, Harper B, Watt KM, Lewis KC, Capparelli EV, Benjamin DK Jr, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act - Pediatric Trials Network Administrative Core Committee. Use of opportunistic clinical data and a population pharmacokinetic model to support dosing of clindamycin for premature infants to adolescents. Clin Pharmacol Ther. 2014 Oct;96(4):429-37. doi: 10.1038/clpt.2014.134. Epub 2014 Jun 20.
• Hayes LW, Oster RA, Tofil NM, Tolwani AJ. Outcomes of critically ill children requiring continuous renal replacement therapy. J Crit Care. 2009 Sep;24(3):394-400. doi: 10.1016/j.jcrc.2008.12.017. Epub 2009 Mar 27.
• Hornik CP, Benjamin DK Jr, Smith PB, Pencina MJ, Tremoulet AH, Capparelli EV, Ericson JE, Clark RH, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act-Pediatric Trials Network. Electronic Health Records and Pharmacokinetic Modeling to Assess the Relationship between Ampicillin Exposure and Seizure Risk in Neonates. J Pediatr. 2016 Nov;178:125-129.e1. doi: 10.1016/j.jpeds.2016.07.011. Epub 2016 Aug 10.
• Hornik CP, Gonzalez D, van den Anker J, Atz AM, Yogev R, Poindexter BB, Ng KC, Delmore P, Harper BL, Melloni C, Lewandowski A, Gelber C, Cohen-Wolkowiez M, Lee JH; Pediatric Trial Network Steering Committee. Population Pharmacokinetics of Intramuscular and Intravenous Ketamine in Children. J Clin Pharmacol. 2018 Aug;58(8):1092-1104. doi: 10.1002/jcph.1116. Epub 2018 Apr 20.
• Hornik CP, Yogev R, Mourani PM, Watt KM, Sullivan JE, Atz AM, Speicher D, Al-Uzri A, Adu-Darko M, Payne EH, Gelber CE, Lin S, Harper B, Melloni C, Cohen-Wolkowiez M, Gonzalez D; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Population Pharmacokinetics of Milrinone in Infants, Children, and Adolescents. J Clin Pharmacol. 2019 Dec;59(12):1606-1619. doi: 10.1002/jcph.1499. Epub 2019 Jul 17.
• Husain A, Loehle JA, Hein DW. Clinical pharmacogenetics in pediatric patients. Pharmacogenomics. 2007 Oct;8(10):1403-11. Review.
• Jones JT, Talib N, Lovell D, Becker ML. Clinical Features and Treatment of Down Syndrome Arthropathy: Experience from Two US Tertiary Hospitals. Paediatr Drugs. 2019 Feb;21(1):33-39. doi: 10.1007/s40272-018-0322-0.
• Kaddourah A, Basu RK, Bagshaw SM, Goldstein SL; AWARE Investigators. Epidemiology of Acute Kidney Injury in Critically Ill Children and Young Adults. N Engl J Med. 2017 Jan 5;376(1):11-20. doi: 10.1056/NEJMoa1611391. Epub 2016 Nov 18.
• Kearns GL, Artman M. Functional Biomarkers: an Approach to Bridge Pharmacokinetics and Pharmacodynamics in Pediatric Clinical Trials. Curr Pharm Des. 2015;21(39):5636-42. Review.
• Le J, Poindexter B, Sullivan JE, Laughon M, Delmore P, Blackford M, Yogev R, James LP, Melloni C, Harper B, Mitchell J, Benjamin DK Jr, Boakye-Agyeman F, Cohen-Wolkowiez M. Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates. Ther Drug Monit. 2018 Feb;40(1):103-108. doi: 10.1097/FTD.0000000000000466.
• Lewis SJ, Mueller BA. Antibiotic dosing in critically ill patients receiving CRRT: underdosing is overprevalent. Semin Dial. 2014 Sep-Oct;27(5):441-5. doi: 10.1111/sdi.12203.
• Long D, Koren G, James A. Ethics of drug studies in infants: how many samples are required for accurate estimation of pharmacokinetic parameters in neonates? J Pediatr. 1987 Dec;111(6 Pt 1):918-21.
• Nolin TD, Aronoff GR, Fissell WH, Jain L, Madabushi R, Reynolds K, Zhang L, Huang SM, Mehrotra R, Flessner MF, Leypoldt JK, Witcher JW, Zineh I, Archdeacon P, Roy-Chaudhury P, Goldstein SL; Kidney Health Initiative. Pharmacokinetic assessment in patients receiving continuous RRT: perspectives from the Kidney Health Initiative. Clin J Am Soc Nephrol. 2015 Jan 7;10(1):159-64. doi: 10.2215/CJN.05630614. Epub 2014 Sep 4.
• Odetola FO, Clark SJ, Freed GL, Bratton SL, Davis MM. A national survey of pediatric critical care resources in the United States. Pediatrics. 2005 Apr;115(4):e382-6.
• Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55.
• Padmakumar B, Evans Jones LG, Sills JA. Is arthritis more common in children with Down syndrome? Rheumatology (Oxford). 2002 Oct;41(10):1191-3.
• Peeters MA, Rethore MO, Lejeune J. In vivo folic acid supplementation partially corrects in vitro methotrexate toxicity in patients with Down syndrome. Br J Haematol. 1995 Mar;89(3):678-80.
• Phan H, Leder M, Fishley M, Moeller M, Nahata M. Off-label and unlicensed medication use and associated adverse drug events in a pediatric emergency department. Pediatr Emerg Care. 2010 Jun;26(6):424-30. doi: 10.1097/PEC.0b013e3181e057e1.
• Pritchard M, Reeves RH, Dierssen M, Patterson D, Gardiner KJ. Down syndrome and the genes of human chromosome 21: current knowledge and future potentials. Report on the Expert workshop on the biology of chromosome 21 genes: towards gene-phenotype correlations in Down syndrome. Washington D.C., September 28-October 1, 2007. Cytogenet Genome Res. 2008;121(1):67-77. doi: 10.1159/000124384. Epub 2008 May 7.
• Pullen J, Stolk LM, Nieman FH, Degraeuwe PL, van Tiel FH, Zimmermann LJ. Population pharmacokinetics and dosing of amoxicillin in (pre)term neonates. Ther Drug Monit. 2006 Apr;28(2):226-31.
• Ricci Z, Goldstein SL. Pediatric Continuous Renal Replacement Therapy. Contrib Nephrol. 2016;187:121-30. doi: 10.1159/000442370. Epub 2016 Feb 8. Review.
• Sherwin J, Heath T, Watt K. Pharmacokinetics and Dosing of Anti-infective Drugs in Patients on Extracorporeal Membrane Oxygenation: A Review of the Current Literature. Clin Ther. 2016 Sep;38(9):1976-94. doi: 10.1016/j.clinthera.2016.07.169. Epub 2016 Aug 21. Review.
• Srinivasan V, Nadkarni VM, Helfaer MA, Carey SM, Berg RA; American Heart Association National Registry of Cardiopulmonary Resuscitation Investigators. Childhood obesity and survival after in-hospital pediatric cardiopulmonary resuscitation. Pediatrics. 2010 Mar;125(3):e481-8. doi: 10.1542/peds.2009-1324. Epub 2010 Feb 22.
• Taub JW, Ge Y. Down syndrome, drug metabolism and chromosome 21. Pediatr Blood Cancer. 2005 Jan;44(1):33-9. Review.
• Taub JW, Huang X, Matherly LH, Stout ML, Buck SA, Massey GV, Becton DL, Chang MN, Weinstein HJ, Ravindranath Y. Expression of chromosome 21-localized genes in acute myeloid leukemia: differences between Down syndrome and non-Down syndrome blast cells and relationship to in vitro sensitivity to cytosine arabinoside and daunorubicin. Blood. 1999 Aug 15;94(4):1393-400.
• Tremoulet A, Le J, Poindexter B, Sullivan JE, Laughon M, Delmore P, Salgado A, Ian-U Chong S, Melloni C, Gao J, Benjamin DK Jr, Capparelli EV, Cohen-Wolkowiez M; Administrative Core Committee of the Best Pharmaceuticals for Children Act-Pediatric Trials Network. Characterization of the population pharmacokinetics of ampicillin in neonates using an opportunistic study design. Antimicrob Agents Chemother. 2014 Jun;58(6):3013-20. doi: 10.1128/AAC.02374-13. Epub 2014 Mar 10.
• Typpo KV, Petersen NJ, Hallman DM, Markovitz BP, Mariscalco MM. Day 1 multiple organ dysfunction syndrome is associated with poor functional outcome and mortality in the pediatric intensive care unit. Pediatr Crit Care Med. 2009 Sep;10(5):562-70. doi: 10.1097/PCC.0b013e3181a64be1.
• Uffmann M, Rasche M, Zimmermann M, von Neuhoff C, Creutzig U, Dworzak M, Scheffers L, Hasle H, Zwaan CM, Reinhardt D, Klusmann JH. Therapy reduction in patients with Down syndrome and myeloid leukemia: the international ML-DS 2006 trial. Blood. 2017 Jun 22;129(25):3314-3321. doi: 10.1182/blood-2017-01-765057. Epub 2017 Apr 11.
• Wade KC, Wu D, Kaufman DA, Ward RM, Benjamin DK Jr, Sullivan JE, Ramey N, Jayaraman B, Hoppu K, Adamson PC, Gastonguay MR, Barrett JS; National Institute of Child Health and Development Pediatric Pharmacology Research Unit Network. Population pharmacokinetics of fluconazole in young infants. Antimicrob Agents Chemother. 2008 Nov;52(11):4043-9. doi: 10.1128/AAC.00569-08. Epub 2008 Sep 22.
• Wang L, McGregor TL, Jones DP, Bridges BC, Fleming GM, Shirey-Rice J, McLemore MF, Chen L, Weitkamp A, Byrne DW, Van Driest SL. Electronic health record-based predictive models for acute kidney injury screening in pediatric inpatients. Pediatr Res. 2017 Sep;82(3):465-473. doi: 10.1038/pr.2017.116. Epub 2017 May 31.
• Watson RS, Crow SS, Hartman ME, Lacroix J, Odetola FO. Epidemiology and Outcomes of Pediatric Multiple Organ Dysfunction Syndrome. Pediatr Crit Care Med. 2017 Mar;18(3_suppl Suppl 1):S4-S16. doi: 10.1097/PCC.0000000000001047. Review.
• Watt K, Li JS, Benjamin DK Jr, Cohen-Wolkowiez M. Pediatric cardiovascular drug dosing in critically ill children and extracorporeal membrane oxygenation. J Cardiovasc Pharmacol. 2011 Aug;58(2):126-32. doi: 10.1097/FJC.0b013e318213aac2. Review.
• Zheng H, Webber S, Zeevi A, Schuetz E, Zhang J, Lamba J, Bowman P, Burckart GJ. The MDR1 polymorphisms at exons 21 and 26 predict steroid weaning in pediatric heart transplant patients. Hum Immunol. 2002 Sep;63(9):765-70.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04278404
• Other Study ID Numbers: Pro00103838
• First Posted: Feb 20, 2020
• Last Update Posted: Dec 15, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Coronavirus Infections; Urinary Tract Infections; Pulmonary Arterial Hypertension; Bronchopulmonary Dysplasia; Down Syndrome; Menorrhagia; Hypertension; Hemostatic Disorders; Mucocutaneous Lymph Node Syndrome; Blood Coagulation Disorders; Hyperphosphatemia; Hypokalemia; Adrenal Insufficiency; Hyperaldosteronism; Disease; Syndrome; Hemorrhage; Attention Deficit Disorder with Hyperactivity; Metformin; Interferons; Ritonavir; Ribavirin; Lopinavir; Oseltamivir; Remdesivir; Azithromycin; Clindamycin; Meropenem; Voriconazole; Ceftazidime; Fosfomycin; Cefepime; Cefdinir; Dexamethasone; Budesonide; Hydrocortisone; Colchicine; Amiodarone; Bosentan; Guanfacine; Labetalol; Nicardipine; Nifedipine; Milrinone; Furosemide; Spironolactone; Dexmedetomidine; Oxycodone; Gabapentin; Nalbuphine; Clobazam; Zolpidem; Risperidone; Amphetamine; Dextroamphetamine; Sertraline; Tranexamic Acid; Aminocaproic Acid; Terbutaline; Sevelamer

Study Results

No Results Posted as of Dec 15, 2021