Pharmacokinetics of Ampicillin in Neonates With Moderate to Severe Hypoxic-Ischemic Encephalopathy

Completed

Conditions studied: Hypothermia

In brief

Controlled Hypothermia has become the standard of care for neonates with moderate to severe HIE. Ampicillin and aminoglycosides are drugs that are universally used for the treatment of suspected neonatal sepsis, which may or may not be responsible for the etiology of HIE. Currently, medication dosage regimens are not altered in the setting of CH. A better understanding of the effects of our interventions on this unique population may help us tailor our therapy to the specific circumstances of the patient

Key facts

Study ID

NCT03129620

Run by

Drexel University

People needed

14

Starts

2013-03-01

Expected to finish

2016-04-01

Last updated by the study team

2017-04-26

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Gestational age > 36 weeks
• Birth weight > 1800 grams
• Age < 6 hours old at the time of admission to the NICU
• Cord gas or ABG/VBG with pH < 7.0 or base deficit > 16 within the first hour of life
• Presence of seizures or evidence of moderate to severe encephalopathy
• Presence of central line for lab draws

You may not qualify if…

• Infants admitted for CH without central intravascular access.

Where it is running

• St Christopher's Hospital for children — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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