The PTN conducts Phase 1-4 trials and data-based studies across a broad range of conditions affecting pediatric patients.
ONGOING STUDIES
| Study Name | Status | Population | Condition | Study Type | ClinicalTrials.gov ID | DASH Submission |
|---|---|---|---|---|---|---|
| Anesthetics and Analgesics in Children (ANA) | Enrolling | Children (<18 y) | Anesthetic and analgesic drugs of interest (DOIs) | Prospective, multi-center, open-label PK and safety profile study | NCT03427736 | |
| Pharmacokinetic and Safety of Antiretroviral and Related Drugs in Lactating Women and Breastmilk Fed Infants (BMS02) | Enrolling | Breastfeeding mothers and infants | Various (drugs administered regularly by physicians) | Intervention | NCT04862975 | |
| Commonly used drugs during lactation and infant exposure (CUDDLE) | Enrolling | Breastfeeding mothers and infants | Various (drugs administered regularly by physicians) | Interventional | NCT03511118 | |
| POP02 | Enrolling | Children (<21 y) | Various (drugs administered regularly by physicians) | Observational | NCT04278404 | |
| Sildenafil II | Enrolling | Premature infants | Bronchopulmonary dysplasia | Phase 2 | NCT03142568 | |
| Terbutaline Sulfate in Adults With Asthma (TBS02) | Enrolling | Adults | Asthma | Interventional | NCT04973345 |
COMPLETED STUDIES
| Study Name | Status | Population | Condition | Study Type | ClinicalTrials.gov ID | DASH Submission |
|---|---|---|---|---|---|---|
| Acyclovir | FDA label changed | Premature infants | Systemic infection | Phase 1 | NCT00942084 | Data collection completed 6/4/2012 |
| Acyclovir retrospective | FDA label changed | Infants | Herpes simplex virus | Retrospective data collection | Data collection completed 6/4/2012 | |
| Ampicillin | FDA label changed | Infants | Bacterial infections including sepsis and meningitis | Secondary data analysis | Data collection completed 11/1/2010 | |
| Anti-epileptic obesity | Analysis ongoing | Obese children | Epilepsy | Interventional | NCT02993861 | Data collection completed 9/3/2019 |
| Antibiotic safety (SCAMP) | Completed | Premature infants | Intra-abdominal infections | Interventional | NCT01994993 | Data collection completed 3/21/2017 |
| Anti-staph trio | Completed | Premature infants | Staphylococcal infections | Interventional | NCT01728363 | Data collection completed 5/7/2015 (Rifampin) |
| Baby TAPE | Completed | Newborns and young infants | NA (Weight estimation tool) | Interventional | NCT01507090 | |
| Baby TAPE III | Completed | Newborns and young infants | NA (Weight estimation tool) | Interventional | ||
| Caffeine | FDA label changed | Premature infants and infants | Bronchopulmonary dysplasia | Retrospective data collection | Data available on DASH | |
| Clindamycin obesity | FDA label changed | Obese children | Staphylococcal infections | Phase 1 | NCT01744730 | Data collection completed 3/8/2014 |
| Digoxin | Analysis ongoing | Children (<6 m) | Single ventricle congenital heart disease | Phase I | NCT03877965 | |
| Diuretic safety | Completed | Infants | Bronchopulmonary dysplasia | Retrospective observational | NA | |
| Fluconazole safety | Completed | Infants | Candidemia | Meta-analysis | NCT00734539 | Data collection completed 2/8/2013 |
| Furosemide | Analysis ongoing | Premature infants | Bronchopulmonary dysplasia | Interventional | NCT02527798 | Data collection completed 12/31/12 |
| Hydroxyurea | Completed | Children (2-4 y) | Sickle cell anemia or sickle beta-zero thalassemia | Phase 2 | NCT01506544 | Data collection completed 11/22/13 |
| Lisinopril PK | FDA label changed | Children and adolescents (2-17 y) | Kidney transplant; high blood pressure | Interventional | NCT01491919 | |
| Long-term Antipsychotic Pediatric Safety Trial (LAPS) | Participation ongoing | Children | Mono-antipsychotic therapies | Observational | NCT03522168 | |
| Lorazepam | FDA label changed | Children and adolescents (3 mo-18 y) | Status epilepticus (Status 1) | Interventional | NCT00114569 | |
| Lorazepam or diazepam | Completed | Children and adolescents (3 mo-18 y) | Pediatric status epilepticus (Status 2) | Interventional | NCT00621478 | Data collection completed 3/13/2012 |
| Meropenem | FDA label change | Infants | Intra-abdominal infections | Interventional | NCT00621192 | Data collection completed 10/15/09 |
| Methadone 1 | Completed | Children | Opiate withdrawal | Observational | NCT01945736 | Data collection completed 1/30/2015 |
| Methadone 2 |
Enrollment completed | Adults | Pain management and Opioid Use Disorder | Interventional | NCT05425420 | |
| Metronidazole | Completed | Premature infants | Serious infection caused by anaerobic bacteria | Interventional | NCT01222585 | Data collection completed 11/15/11 |
| Midazolam | Completed | Children (≥2 y) | Seizures | Retrospective data analysis | NA | |
| Obesity informatics | Completed | Children | Various | Systematic literature review | NA | |
| Pantoprazole | Completed | Obese children | GERD | Phase 1 | NCT02186652 | Data collection completed 9/10/15 |
| Pediatrix meta-analysis | Published | Infants | Various | Meta-analysis | NA | |
| Personal protective equipment (PPE) | Completed | Research doctors and nurses | Evaluating impact of various PPE | Interventional | NA | Data collection 9/27/17 |
| POP01 | Analysis ongoing | Children (<21 y) | Various (drugs administered regularly by physicians) | Observational | NCT01431326 | Ampicillin - Opportunistic/PK
Doxycycline - Opportunistic/PK |
| Sildenafil | Completed | Premature infants | Bronchopulmonary dysplasia | Phase 1 | NCT01670136 | Data collection completed 7/26/16 |
| TAPE | FDA label changed | Children (2-16 y) | NA (Mercy Method™ for weight estimation) | Observational | NCT01507090 | Data collection completed 3/29/12 |
| Timolol | Analysis ongoing | Infants | Infantile hemangioma | Phase 2 | NCT02913612 | |
| Trimethoprim-sulfamethoxazole and clindamycin | Completed | Children | Skin and soft tissue infections | Data from 3 protocols |
