The goal of this clinical trial is to learn if preterm infants who are prescribed antibiotics shortly after birth can safety receive a shorter course of antibiotics (24 to 36 hours instead of 48 hours). The main questions it aims to answer are:
* Does short-course ampicillin provide high enough levels of ampicillin at 48 hours?
* Is short-course ampicillin safe for preterm infants to receive?
Preterm infants who are being prescribed ampicillin by their doctor and enroll in the study will stop ampicillin after a shorter than typical course, and researchers will collect blood samples to measure their ampicillin levels and follow them clinically to see how they do after receiving short-course ampicillin.
Participants will:
* stop ampicillin earlier than 48 hours (between 24 to 36 hours, depending on how premature they are and the dosing of ampicillin their doctor has prescribed)
* have a blood sample collected around 48 hours from when they started ampicillin
* have their data collected until 30 days after they receive short-course ampicillin, or until hospital discharge, whichever is sooner
Who can participate
Age range
0 Days – 7 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Documented informed consent from parent/guardian
* Infants admitted to the Duke Neonatal Intensive Care Unit (NICU)
* less than or equal to 34 completed weeks gestational age (GA) at birth and \< 7 days of life at time of screening
* Prescribed ampicillin by provider per standard of care for evaluation of early onset sepsis
Exclusion Criteria:
* Infant on extracorporeal support (e.g., ECMO)
* Positive blood culture or other confirmed infection
* At time of consent, infants with GA \<28 completed weeks who have received more than 24 hours of empiric ampicillin OR infants with GA 28 to 34 completed weeks who have received \> 32 to 36 hours of ampicillin, depending on dosing regimen
* Has major congenital abnormalities where survival to 30 days of life is not expected
* Failure to obtain consent from parent/guardian
* Receives a course of ampicillin that is longer (i.e., more doses) than the short-course defined regimen for their GA
* Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Free plasma ampicillin concentration
Timeframe: data will be collected up to 50 hours from the first dose of ampicillin