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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03129620
Recruitment Status : Completed
First Posted : April 26, 2017
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Ogechukwu Menkiti, Drexel University

Brief Summary:
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

Condition or disease
Hypothermia

Detailed Description:

Hypoxic-ischemic encephalopathy (HIE) affects approximately 1 to 2 per 1000 live births and remains a cause of significant morbidity and mortality in the neonatal period. In response to an anoxic insult, perfusion to vital organs is preserved; however, when this injury is profound concomitant injury to nonvital organs is observed. Controlled hypothermia (CH) has been accepted as a neuroprotective therapeutic modality for neonates with moderate to severe HIE because of its role in attenuating secondary brain injury. Neonates exhibit varying degrees of multiorgan dysfunction after a hypoxic-ischemic insult, although the added beneficial and potential adverse effects that CH has in these babies have not been completely delineated or understood.

CH has been shown to alter normal physiologic functioning of several organ systems. Specific physiologic changes as a consequence of CH have been demonstrated in both animal and human models. The observed reduction in cardiac output and reflexive increase in systemic vascular resistance in response to CH alter renal perfusion and subsequently reduce glomerular filtration . Drugs that are renally cleared may develop a prolonged half-life in this setting. Finally, drug metabolism may further be affected by altered hepatic blood flow and temperature-dependent effects on hepatic enzyme activity . Collectively, the potential effects of CH on drug metabolism and clearance are significant warranting further investigation. The investigator aims to evaluate the combined effects of hypoxia and hypothermia on ampicillin clearance and excretion


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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pharmacokinetics of Ampicillin in Neonates With Moderate to Severe Hypoxic-Ischemic Encephalopathy Undergoing Controlled Hypothermia
Study Start Date : March 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia




Primary Outcome Measures :
  1. Elevated ampicillin serum levels [ Time Frame: 3 years ]
    Ampicillin concentration at 3 time points to determine clearance and serum levels



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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neonates 0-24 hours of life
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

• Infants admitted for CH without central intravascular access.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03129620


Locations
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United States, Pennsylvania
St Christopher's Hospital for children
Philadelphia, Pennsylvania, United States, 19134
Sponsors and Collaborators
Drexel University

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Responsible Party: Ogechukwu Menkiti, md, Drexel University
ClinicalTrials.gov Identifier: NCT03129620     History of Changes
Other Study ID Numbers: 1301001808
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ogechukwu Menkiti, Drexel University:
Ampicillin

Additional relevant MeSH terms:
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Ampicillin
Hypothermia
Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Body Temperature Changes
Signs and Symptoms
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain
Anti-Bacterial Agents
Anti-Infective Agents