Pharmacokinetics of Ampicillin in Neonates With Moderate to Severe Hypoxic-Ischemic Encephalopathy
1 other identifier
observational
14
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 18, 2016
CompletedFirst Posted
Study publicly available on registry
April 26, 2017
CompletedApril 26, 2017
April 1, 2017
3 years
September 18, 2016
April 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Elevated ampicillin serum levels
Ampicillin concentration at 3 time points to determine clearance and serum levels
3 years
Eligibility Criteria
Neonates 0-24 hours of life
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St Christopher's Hospital for children
Philadelphia, Pennsylvania, 19134, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- md
Study Record Dates
First Submitted
September 18, 2016
First Posted
April 26, 2017
Study Start
March 1, 2013
Primary Completion
March 1, 2016
Study Completion
April 1, 2016
Last Updated
April 26, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share