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Sildenafil Results-at-a-Glance

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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.

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Oxycodone Results-at-a-Glance

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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.

Fluconazole Results-at-a-Glance

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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.

Ticarcillin-clavulanate Results-at-a-Glance

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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.

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Clindamycin Results-at-a-Glance

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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.

 

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Metronidazole Results-at-a-Glance

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Metronidazole is an antibiotic that is often used when treating infants with complicated intra-abdominal infections. However, the medicine is not approved for use in infants by the U.S. Food and Drug Administration (FDA). This study was needed to learn more about the safest and most effective dosage of metronidazole for treating cIAIs in infants.

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PPE Results-at-a-Glance

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Personal protective equipment (PPE) is worn by health care providers to protect them from exposure to hazardous materials such as chemicals or infectious diseases. Previous studies examining the effects of PPE on health care providers’ ability to perform emergency tasks have had mixed results. Additionally, there have not been studies evaluating the performance of these tasks on children while wearing PPE. These studies were needed to determine how PPE impacts health care providers’ ability to perform emergency care for pediatric groups.

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babyTAPE Results-at-a-Glance

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There are several existing weight estimation formulas for children, but most are for older children and cannot be applied to infants 0-90 days old. The babyTAPE studies developed a formula and device to fill this gap and accurately estimate the weight of infants.

Ampicillin Results-at-a-Glance

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Ampicillin, a medicine used to treat infections, is the most commonly used drug in babies born prematurely who are admitted to the hospital. At the same time, practically no one has ever figured out how the drug is processed in newborns. The goal of the “Ampicillin in Infants Study” was to find out how newborns process ampicillin and determine the safest and most effective dose to treat infections.

Caffeine Citrate Results-at-a-Glance

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Almost all infants born at less than 29 weeks gestational age develop apnea of prematurity (AOP). Caffeine citrate is often used in the neonatal intensive care unit (NICU) to treat AOP. However, the drug label for caffeine citrate was last updated by the FDA in 1999. This label recommends short-term use of the drug for premature infants 28 – 33 weeks gestational age, but caffeine citrate is frequently used in
infants born earlier. This study was needed to identify the association of caffeine citrate use and safety in infants less than 29 weeks gestational age and to bridge the gap in caffeine citrate’s label recommendations and current clinical practice.