A Pilot Randomized Controlled Trial for Antibiotic Exposure in Neonatal Sepsis Using Neutrophil CD64

Not Applicable

Withdrawn

• Conditions: Neonatal Early-onset Sepsis; Neonatal Late-onset Sepsis
• Interventions: Other: Intervention is to stop antibiotics at 24h .

• Registration Number: NCT01825421
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-02
• Study First Submitted QC: 2013-04-04
• Study First Posted: 2013-04-05
• Study Start: 2014-10
• Status Verified: 2015-07
• Primary Completion: 2016-01
• Study Completion: 2016-06
• Last Update Submitted: 2020-03-27
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Infants undergoing a sepsis evaluation in the NICU

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Exclusion Criteria

• They have a major life-threatening congenital malformation
• The attending neonatologist has objections to the infant participating in the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study (discontinue antibiotics) group	Intervention is to stop antibiotics at 24h .	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in the Neutrophil CD64 Index value in neonates with/without exposure to antibiotics from 24h to 48h.	At 48h after initiation of antibiotics.

Trial Locations

Locations (1)

Yale-New Haven Children's Hospital NICU; 🇺🇸 New Haven, Connecticut, United States