Purpose of this Study
Babies in this study will be followed while they are in the hospital, for up to 30 days or until they go home, whichever comes first. Babies who receive a short course of the antibiotic ampicillin will have a small blood sample taken about two days after the medicine is started to see how the drug is working in their body. Some babies may have extra blood samples taken if they are already having routine lab tests, but this is not required. The study team will also collect basic information about the baby, their medical care, and details about the blood samples to help researchers learn more.
Who Can Participate?
Eligibility
This study is for premature babies who were born early at 34 weeks of pregnancy or sooner and are less than 7 days old. These babies are already receiving an antibiotic called ampicillin as part of their normal medical care. The study will include about 60 babies and will help researchers learn more about how this medicine works in young infants.
Age Range
0
Sex/Genders
Male (cisgender)
Female (cisgender)
Looking for Healthy Participants
No
What is Involved?
Description
This study is looking at how long antibiotics stay active in the bodies of premature babies. Research has shown that the antibiotic ampicillin may keep working even after doctors stop giving it. Because of this, doctors are wondering if babies can safely receive the medicine for a shorter time, such as one to one and a half days instead of two days.
The goal of the study is to check if this shorter treatment is safe and still protects babies from infection. Researchers hope this could help reduce how much medicine babies need while still keeping them safe.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
An open-label, pharmacokinetic and safety trial Optimizing PreTerm Infant Ampicillin dosing
Principal Investigator
Angelique
Boutzoukas
Protocol Number
PRO00119855
NCT ID
NA
Phase
I/II
Enrollment Status
Pending Open to Enrollment