The PTN conducts Phase 1-4 trials and data-based studies across a broad range of conditions affecting pediatric patients. View the table below to explore ongoing and completed PTN studies.
To find the current FDA-approved drug label, you can use two reliable sources — Drugs@FDA provides current and archived labels, plus approval letters and review documents while DailyMed provides the current label. Get step-by-step instructions to find current labels.
Please view this document for label changes prior to 2022.
ONGOING STUDIES
| Study Name | Drug(s) | Study Type | Population | Status | CT.gov |
|---|---|---|---|---|---|
| Anesthetics and Analgesics in Children (ANA) | Morphine Ketamine Oxycodone |
Prospective, multi-center, open-label PK and safety profile study | Children (<18 y) | Enrolling | NCT03427736 |
| Commonly Used Drugs During Lactation and Infant Exposure (CUDDLE) | Cyclobenzaprine Trazadone Amoxicillin Buprenorphine Duloxetine Hydrocodone Levetiracetam |
Prospective, multi-center, open-label PK and safety profile study | Breastfeeding mothers and infants | Enrolling | NCT03511118 |
| Pharmacokinetics and Pharmacodynamics of Understudied Drugs in Children and Infants (POP02) | Multiple DOIs | Prospective, multi-center, open-label PK and safety | Children (<21 y) | Enrolling | NCT04278404 |
COMPLETED STUDIES
| Drug Name | Status | Population | Condition | Study Type | CT.gov | Data Collection End Date |
|---|---|---|---|---|---|---|
| Acyclovir | FDA label changed | Premature infants | Systemic infection | Phase 1 | NCT00942084 | 6/4/2012 |
| Acyclovir retrospective | FDA label changed | Infants | Herpes simplex virus | Retrospective data collection | NA | 6/4/2012 |
| Ampicillin | FDA label changed | Infants | Bacterial infections including sepsis and meningitis | Secondary data analysis | NA | 11/1/2010 |
| Anti-epileptic Obesity | Analysis | Obese children | Epilepsy | Interventional | NCT02993861 | 9/3/2019 |
| Aripiprazole Long-term Antipsychotic Pediatric Safety Trial (LAPS01) |
Analysis | Children | Psychiatric disorders | Observational | NCT03522168 | 11/21/2023 |
| Azithromycin (CUDDLE) | Analysis | Breastfeeding mothers and infants | Staphylococcal infections | Prospective, multi-center, open-label PK and safety profile study | NCT03511118 | |
| Baby TAPE | Completed | Newborns and young infants | NA (Weight estimation tool) | Interventional | NCT01507090 | 03/29/2012 |
| Baby TAPE III | Completed | Newborns and young infants | NA (Weight estimation tool) | Interventional | NA | 9/11/2017 |
| Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants (BMS02) | Analysis | Breastfeeding mothers and infants | HIV/AIDS | Intervention | NCT04862975 | 1/30/2025 |
| Bupropion (CUDDLE) |
Analysis | Breastfeeding mothers and infants | Prospective, multi-center, open-label PK and safety profile study | NCT03511118 | ||
| Caffeine | FDA label changed | Premature infants and infants | Bronchopulmonary dysplasia | Retrospective data collection | NA | |
| Citalopram (CUDDLE) |
Analysis | Breastfeeding mothers and infants | Prospective, multi-center, open-label PK and safety profile study | NCT03511118 | ||
| Clindamycin (CUDDLE) | Analysis | Breastfeeding mothers and infants | Prospective, multi-center, open-label PK and safety profile study | NCT03511118 | 3/8/2014 | |
| Clindamycin Obesity | FDA label changed | Obese children | Staphylococcal infections | Phase 1 | NCT01744730 | 3/8/2014 |
| Digoxin | Analysis | Children (<6 m) | Single ventricle congenital heart disease | Phase 1 | NCT03877965 | 1/17/2022 |
| Escitalopram (CUDDLE) |
Analysis | Breastfeeding mothers and infants | Prospective, multi-center, open-label PK and safety profile study | NCT03511118 | ||
| Fluconazole | FDA label changed | Infants | Candidemia | Meta-analysis | NCT00734539 | 2/8/2013 |
| Furosemide | FDA label changed | Premature infants | Bronchopulmonary dysplasia | Interventional | NCT02527798 | 12/31/2012 |
| Gabapentin (CUDDLE) |
Analysis | Breastfeeding mothers and infants | Prospective, multi-center, open-label PK and safety profile study | NCT03511118 | ||
| Guanfacine (HYP01) | Analysis | Children and adolescents | ADHD; Down Syndrome | Interventional | NCT06042257 | 08/12/2025 |
| Guanfacine (POP02) |
Analysis | Children (<21y) | Observational | NCT04278404 | ||
| Hydromorphone (ANA01) | Analysis | Children (<18 y) | Pain | Observational | NCT03427736 | |
| Hydroxyurea | Completed | Children (2-4 y) | Sickle cell anemia or sickle beta-zero thalassemia | Phase 2 | NCT01506544 | 11/22/2013 |
| Ketorolac (ANA01) | Analysis | Children (<18 y) | Pain | Observational | NCT03427736 | |
| Labetalol (CUDDLE) | Analysis | Breastfeeding mothers and infants | Prospective, multi-center, open-label PK and safety profile study | NCT03511118 | ||
| Levetiracetam (AED) | FDA label changed | Obese children | Epilepsy | Observational | NCT02993861 | 9/3/2019 |
| Lisinopril | FDA label changed | Children and adolescents (2-17 y) | Phase 1 | NCT01491919 | 10/16/2013 | |
| Long-term Antipsychotic Pediatric Safety Trial (LAPS) | Analysis | Children | Mono-antipsychotic therapies | Observational | NCT03522168 | |
| Lorazepam | FDA label changed | Children and adolescents (3 mo-18 y) | Status epilepticus (Status 1) | Interventional | NCT00114569 | |
| Lorazepam and diazepam | Completed FDA label changed for diazepam | Children and adolescents (3 mo-18 y) | Pediatric status epilepticus (Status 2) | Interventional | NCT00621478 | 3/13/2012 |
| Meropenem | FDA label changed | Infants | Intra-abdominal infections | Interventional | NCT00621192 | 10/15/2009 |
| Metformin (CUDDLE) | Analysis | Breastfeeding mothers and infants | Prospective, multi-center, open-label PK and safety profile study | NCT03511118 | ||
| Methadone 1 | Completed | Children | Opiate withdrawal | Observational | NCT01945736 | 1/30/2015 |
| Methadone 2 |
Analysis | Adults | Pain management and Opioid Use Disorder | Interventional | NCT05425420 | |
| Metronidazole | FDA Label Changed | Premature infants | Serious infection caused by anaerobic bacteria | Interventional | NCT01222585 | 11/15/2011 |
| Metronidazole (Antibiotic Safety SCAMP) |
Completed | Premature infants | Intra-abdominal infections | Interventional | NCT01994993 | 3/21/2017 |
| Midazolam | Completed | Children (≥2 y) | Seizures | Retrospective data analysis | NA | |
| Nifedipine (CUDDLE) | Analysis | Breastfeeding mothers and infants | Prospective, multi-center, open-label PK and safety profile study | NCT03511118 | ||
| Obesity informatics | Completed | Children | Various | Systematic literature review | NA | |
| Ondansetron (CUDDLE) |
FDA label changed | Mothers and infants | Observational | NCT03511118 | ||
| Oxcarbazepine (AED) | FDA label changed | Obese children | Epilepsy | Observational | NCT02993861 | 10/17/2019 |
| Oxycodone (CUDDLE) |
FDA label changed | Breastfeeding mothers and infants | Pain | Observational | NCT03511118 | |
| Oxycodone (POP01/POP02) |
Analysis | Children (<21 y) | Pain | Observational | NCT04278404 | |
| Pantoprazole | Completed | Obese children | Gastroesophageal reflux disease | Phase 1 | NCT02186652 | 9/10/2015 |
| 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 | 9/27/2017 |
| Various Drugs of Interest POP01 | Analysis ongoing | Children (<21 y) | Various (drugs administered regularly by clinicians) | Observational | NCT01431326 | 11/21/2023 |
| Rifampin (Anti-staph trio) | Completed | Premature infants | Staphylococcal infections | Phase 1 | NCT01728363 | 5/7/2015 |
| Risperidone (LAPS01) | Analysis | Children | Psychiatric disorders | Observational | NCT03522168 | 11/21/2023 |
| Sertraline (CUDDLE) |
Analysis | Breastfeeding mothers and infants | Prospective, multi-center, open-label PK and safety profile study | NCT03511118 | ||
| Sildenafil | Completed | Premature infants | Bronchopulmonary dysplasia | Phase 1 | NCT01670136 | 7/26/2016 |
| Sildenafil II | Analysis | Premature infants | Bronchopulmonary dysplasia | Phase 2 | NCT03142568 | 03/01/2025 |
| TAPE | FDA label changed | Children (2-16 y) | NA (Mercy Method™ for weight estimation) | Observational | NCT01507090 | 3/29/2012 |
| Timolol | Analysis ongoing | Infants | Infantile hemangioma | Phase 2 | NCT02913612 | 10/20/2020 |
| Topiramate (AED) | FDA label changed | Obese children | Epilepsy | Observational | NCT02993861 | 10/17/2019 |
| Tranexamic Acid (CUDDLE) |
Analysis | Breastfeeding mothers and infants | Prospective, multi-center, open-label PK and safety profile study | NCT03511118 | ||
| Trimethoprim-sulfamethoxazole and clindamycin
|
Completed FDA label changed for TMP-SMX |
Children | Skin and soft tissue infections | Observational | NCT01431326, NCT01728363, NCT01744730 | 08/2014 (CLN01); 05/2015 (STA01); 11/2019 (POP01 |
| Valproic Acid (AED) | Analysis | Obese Children | Epilepsy | Observational | NCT02993861 | 10/17/2019 |
| Venlafaxine (CUDDLE) |
Analysis | Breastfeeding mothers and infants | Prospective, multi-center, open-label PK and safety profile study | NCT03511118 |