Read the lorazepam Results-at-a-Glance summary.
Status epilepticus (SE) is a serious condition that affects the brain. SE can be caused by medical conditions, illnesses, or injuries. A preferred treatment for SE is lorazepam. However, lorazepam is not approved by the FDA for children under 18 years old. This summary is for a study performed by the Pediatric Trials Network (PTN). The study was needed to find out how children with SE process lorazepam.
Read the oxcarbazepine Results-at-a-Glance summary.
Oxcarbazepine is a medicine that is approved by the U.S. Food and Drug Administration (FDA) for treating seizures in adults and children older than two years. However, guidance for children who have obesity was lacking. This study was needed to learn how a child’s obesity status affects the way they process oxcarbazepine.
Read diazepam Results-at-a-Glance summary.
Diazepam is a medicine approved by the U.S. Food and Drug Administration (FDA) for treating severe seizures in children. However, the most safe and effective dosage of diazepam for children was unknown.
Read rifampin Results-at-a-Glance summary.
Rifampin is an FDA approved antibiotic but has not been evaluated for treating staph infection in infants. The purpose of the study was to find out the pharmacokinetics and safety of rifampin in infants with suspected infections.
Read levetiracetam Results-at-a-Glance summary.
Levetiracetam is a medicine that is approved by the U.S. Food and Drug Administration (FDA) for treating seizures in children. However, it is unknown how well the medicine works in children who weigh more than average. These studies were needed to learn how children who are heavier than average weight process levetiracetam and the amount of the medicine they should receive when being treated for seizures.
Read sildenafil Results-at-a-Glance summary.
Infants born too early can get a lung disease called Bronchopulmonary dysplasia (BPD). Infants with BPD are likely to have pulmonary hypertension, a condition where the blood vessels in the lungs get blocked or destroyed, causing high blood pressure. Pulmonary hypertension increases the risk of death from BPD. There are no medicines approved by the U.S. Food and Drug Administration (FDA) for treating BPD. However, doctors often use the medicine sildenafil to manage high blood pressure in infants with BPD.
Read oxycodone Results-at-a-Glance summary.
Oxycodone is a pain-relieving medicine often prescribed to mothers after giving birth. Studies have shown that oxycodone transfers into breastmilk, but data were lacking on how much of it is transferred to a breastfeeding infant. This information was needed for providers and mothers to make the best, safest decisions regarding medicines and breastfeeding. The Pediatric Trials Network (PTN) study called “Commonly Used Drugs During Lactation and Infant Exposure (CUDDLE)” tested medicines, including oxycodone, to learn how they transfer from mother to baby through breastmilk.
Read fluconazole Results-at-a-Glance summary.
Fluconazole is an antifungal medicine often used to treat and prevent yeast infections in infants born prematurely and full-term. In infants, yeast can cause serious infections all throughout the body, including the skin, blood, heart, eyes, and brain. These yeast infections occur because infants have weaker immune systems than older children and adults, and the infections can lead to long-term health issues or even death. Despite the frequent use of fluconazole in infants, there was little data available on the pharmacokinetics, or how the medicine is processed in infants’ bodies.
Read ticarcillin-clavulanate Results-at-a-Glance.
Ticarcillin-clavulanate is an antibiotic that can be used to treat many infections that occur in premature infants. However, there is little information on the pharmacokinetics (how the drug is processed) in premature infants’ bodies. This information is necessary for health care providers to prescribe the safest, most effective dose of ticarcillin-clavulanate when treating infections in premature infants.
Read the clindamycin Results-at-a-Glance summary.
Clindamycin is an antibiotic medicine that is often given to children to treat infections like methicillin-resistant Staphylococcus aureus (MRSA). Despite its common use in children, there is little information on the pharmacokinetics, how the drug is processed, of clindamycin in pediatric groups. These studies were needed to learn the safest, most effective dosage of clindamycin in children ranging in age from premature infants to adolescents.
