Neonatal Early-onset Sepsis Clinical Trial
Official title:
A Pilot Randomized Controlled Trial for Antibiotic Exposure in Neonatal Sepsis Using Neutrophil CD64
| NCT number | NCT01825421 |
| Other study ID # | 1212011184 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 2014 |
| Est. completion date | June 2016 |
| Verified date | July 2015 |
| Source | Yale University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 5 Months |
| Eligibility |
Inclusion Criteria: - Infants undergoing a sepsis evaluation in the NICU Exclusion Criteria: - They have a major life-threatening congenital malformation - The attending neonatologist has objections to the infant participating in the study |
| Country | Name | City | State |
|---|---|---|---|
| United States | Yale-New Haven Children's Hospital NICU | New Haven | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| Yale University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Number of positive blood cultures in neonates from 24h to 48h with/without exposure to antibiotics. | At 48h after initiation of antibiotics. | ||
| Primary | 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 | At 48h after initiation of antibiotics. | ||
| Secondary | Change in the Neutrophil CD64 Index value in neonates with/without exposure to antibiotics from 24h to 48h. | At 48h after initiation of antibiotics. |