An interventional study of Intervention is to stop antibiotics at 24h . in Neonatal Early-onset Sepsis and Neonatal Late-onset Sepsis, sponsored by Yale University. Withdrawn at 1 site in United States. Open to participants aged 1 Hour to 5 Months. Per ClinicalTrials.gov, last updated 2020-03-30.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
Unnecessary and prolonged antibiotic therapy in newborn babies can have serious consequences including development of necrotizing enterocolitis (a serious, potentially life-threatening gastrointestinal illness in premature babies), late-onset infections, resistance to antibiotics, increased length of hospital stay, and death.
Starting and continuing antibiotic therapy for blood culture-negative infections in the neonatal intensive care unit (NICU) is fairly common with numbers of such patients varying from 20%-90% of infants undergoing a sepsis evaluation in the NICU.
While blood culture results are the gold standard, there is usually a delay of up to 48-72h before the results are known. Hence, initiation and continuation of antibiotic treatment are usually based on clinical evaluation and blood count criteria which do not possess high specificity or sensitivity, and may be unreliable in the first few hours after birth or in the early stages of infection.
Since the investigators found that neutrophil CD64 (a type of protein found on the surface of a type of white blood cell that can be detected quickly in a very small amount of blood sample) has high accuracy for early detection of blood culture-proven infections in newborn babies, with extremely high negative predictive value (can identify babies definitively with no infection), the investigators will use this test to decide whether to stop or continue antibiotics in the NICU.
The investigators hypothesis is that neutrophil CD64 values can be safely used to discontinue antibiotics in newborns suspected of having infections.
The investigators aims are to utilize sequential measurements of CD64 values to stop antibiotics early in neonates being investigated for both early and late-onset infections in the NICU.
This is a prospective, randomized, controlled (RCT) trial. The study population will be derived from the sub-set of all newborn infants who have undergone investigations for presence of infection in the NICU.
186 studies on the registry are indexed under Neonatal Sepsis; 42 are open to participants now.
Browse Neonatal Sepsis studies →Yale University is the lead sponsor of 1,763 studies on the registry; 292 are open to participants now.
Of its 217 completed or terminated interventional studies of FDA-regulated products, 128 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The antibiotics will be continued for at least another 24h i.e. for 48h, pending blood culture results at 48h, as per standard practice in the NICU.
The intervention is to discontinue antibiotics at 24h, and he/she will be kept under observation in the NICU for at least an additional 24h, pending blood culture results at 48h.
Other: Intervention is to stop antibiotics at 24h .
Stoppage of antibiotics at 24h in the intervention arm, randomization based on neutrophil CD64 values.
Number of infants with early-onset sepsis (EOS) and late-onset sepsis (LOS) randomized to either stopping or continuing antibiotics at 24h, based on the neutrophil CD64 measurement
Time frame: At 48h after initiation of antibiotics.
Change in the Neutrophil CD64 Index value in neonates with/without exposure to antibiotics from 24h to 48h.
Time frame: At 48h after initiation of antibiotics.
Number of positive blood cultures in neonates from 24h to 48h with/without exposure to antibiotics.
Time frame: At 48h after initiation of antibiotics.
This study is withdrawn, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.