CLINICAL TRIALS PROFILE FOR INFANT'S ADVIL
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505(b)(2) Clinical Trials for Infant's Advil
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| OTC | NCT01732874 ↗ | DHA Supplementation for Lactating Mothers | Completed | Children's Hospital Medical Center, Cincinnati | Phase 1/Phase 2 | 2013-05-01 | The purpose of this research study is to find out whether preterm infants are receiving enough of the essential and long chain fatty acids important for brain development and immune function. Our current intravenous (IV) fats do not contain the long chain fatty acids and different milk sources have different compositions. We would like to evaluate lactating mothers dietary intake and breastmilk level of fatty acid status by doing an analysis of their blood and breastmilk samples after they have been supplemented with a currently used fatty acid supplement (DHA- Martek Biosciences, now known as Dutch State Mines (DSM) Nutritional Lipid) The DHA supplement is available over the counter. The information learned from this research study may benefit other mothers and babies in the future. The information could help make sure premature babies are receiving the right nutrients they need for appropriate growth and development. |
| New Dosage | NCT03608696 ↗ | Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure | Completed | Chiesi Farmaceutici S.p.A. | Phase 1/Phase 2 | 2018-08-29 | Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine. These results were with an empirically derived dose. This study will use pharmacokinetic modeling-informed dosing to clarify the dose/response relationship and use a rational approach to define an optimal dose regimen. The clinical trial will be open label, single arm design with a goal of initial testing of a new dosing regimen. |
| New Dosage | NCT03608696 ↗ | Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure | Completed | Thomas Jefferson University | Phase 1/Phase 2 | 2018-08-29 | Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine. These results were with an empirically derived dose. This study will use pharmacokinetic modeling-informed dosing to clarify the dose/response relationship and use a rational approach to define an optimal dose regimen. The clinical trial will be open label, single arm design with a goal of initial testing of a new dosing regimen. |
| New Formulation | NCT06918665 ↗ | HEALTH Trial - Healthy Adult Evaluation of Ivermectin Bioequivalence: Infant Versus Standard Formulation | NOT_YET_RECRUITING | Monash University | PHASE1 | 2025-11-01 | This is a clinical trial to compare two formulations of the drug ivermectin: the standard 3mg tablet formulation versus a newly developed infant formula preparation. The goal of the trial is to determine if the new formulation functions in the same way, tastes the same and causes no new side effects. The trial will involve 52 participants who will be healthy adult volunteers. The participants will receive both formulations - the order they receive each formulation will be assigned randomly (similar to the toss of a coin). |
| New Formulation | NCT06918665 ↗ | HEALTH Trial - Healthy Adult Evaluation of Ivermectin Bioequivalence: Infant Versus Standard Formulation | NOT_YET_RECRUITING | Murdoch Childrens Research Institute | PHASE1 | 2025-11-01 | This is a clinical trial to compare two formulations of the drug ivermectin: the standard 3mg tablet formulation versus a newly developed infant formula preparation. The goal of the trial is to determine if the new formulation functions in the same way, tastes the same and causes no new side effects. The trial will involve 52 participants who will be healthy adult volunteers. The participants will receive both formulations - the order they receive each formulation will be assigned randomly (similar to the toss of a coin). |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Infant's Advil
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00000494 ↗ | Management of Patent Ductus in Premature Infants | Completed | National Heart, Lung, and Blood Institute (NHLBI) | Phase 3 | 1978-09-01 | To evaluate the effects (up to one year of age) of indomethacin on the clinical course of patent ductus arteriosus (PDA) in premature infants (24 hours old or less) and to assess the relative merits of indomethacin and surgery in infants with persistent respiratory distress who were not treated early with indomethacin. Two concurrent trials were performed. |
| NCT00000563 ↗ | Prevention of Neonatal Respiratory Distress Syndrome With Antenatal Steroid Administration | Completed | National Heart, Lung, and Blood Institute (NHLBI) | Phase 3 | 1976-06-01 | To determine the effect of corticosteroids, administered 24 to 48 hours before parturition, on the incidence of neonatal respiratory distress syndrome (RDS) and to determine whether the therapy has any adverse short- or long-term (up to 36 months) effects on the infant. Secondarily, to determine whether the therapy has any adverse short-term effects on the mother and to determine whether morbidity rates for neonatal respiratory distress syndrome as well as total and cause-specific infant mortality rates differ between mothers who received antenatal steroids and those who received conventional medical care. |
| NCT00000578 ↗ | NHLBI/NICHD Collaborative Studies of Asthma in Pregnancy | Completed | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 3 | 1994-04-01 | To conduct a collaborative program of research on asthma and pregnancy consisting of two studies: the Asthma in Pregnancy Study (APS) was an observational study to evaluate relationships between asthma severity and treatment programs and perinatal outcome, and the Asthma Therapy in Pregnancy Trial (ATPT) was a randomized clinical trial of inhaled beclomethasone versus theophylline in the treatment of moderate asthma during pregnancy. Both studies were conducted in the Maternal-Fetal Medicine Unit (MFMU) Network, an ongoing group of participating obstetric centers supported by the National Institute of Child Health and Human Development. Studies were co-funded by the NHLBI. |
| NCT00000578 ↗ | NHLBI/NICHD Collaborative Studies of Asthma in Pregnancy | Completed | National Heart, Lung, and Blood Institute (NHLBI) | Phase 3 | 1994-04-01 | To conduct a collaborative program of research on asthma and pregnancy consisting of two studies: the Asthma in Pregnancy Study (APS) was an observational study to evaluate relationships between asthma severity and treatment programs and perinatal outcome, and the Asthma Therapy in Pregnancy Trial (ATPT) was a randomized clinical trial of inhaled beclomethasone versus theophylline in the treatment of moderate asthma during pregnancy. Both studies were conducted in the Maternal-Fetal Medicine Unit (MFMU) Network, an ongoing group of participating obstetric centers supported by the National Institute of Child Health and Human Development. Studies were co-funded by the NHLBI. |
| NCT00000580 ↗ | Interruption of Maternal-to-Infant Transmission of Hepatitis B by Means of Hepatitis B Immune Globulin | Completed | National Heart, Lung, and Blood Institute (NHLBI) | Phase 3 | 1975-11-01 | To evaluate whether hepatitis B immune globulin with a high level of antibody against the hepatitis B antigen would be capable of interrupting maternal-fetal transmission of hepatitis B virus, the single most important route of hepatitis spread in the entire Third World. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for Infant's Advil
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Clinical Trial Locations for Infant's Advil
Trials by Country
Clinical Trial Progress for Infant's Advil
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Clinical Trial Sponsors for Infant's Advil
Sponsor Name
| Sponsor Name for Infant's Advil | |
| Sponsor | Trials |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | 73 |
| National Institute of Allergy and Infectious Diseases (NIAID) | 62 |
| Bill and Melinda Gates Foundation | 20 |
| [disabled in preview] | 36 |
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