Neo-SIGHT Version [1.0]
Research type
Research Study
Full title
Neonatal Early Onset Sepsis: Digitally linked pathogen sequencing, immune phenotype and nutritional/developmental assessment to prevent AMR
IRAS ID
349830
Contact name
Abhishek Das
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Delivery of antibiotics to newborn infants is imprecise, because the laboratory tests we have now are not sufficiently accurate to rule-out infection in all cases . Even with gold standard assays e.g. blood cultures, there are challenges. For example, the low blood volumes obtained from neonates means clinician query whether the test results might be false negative due to sensitivity. Additionally, it is clear from post-mortem studies that local infection can occur in the absence bloodstream infection.
This lack of diagnostic certainty means that, physicians often continue treatment (for a median of five days) if bacterial infection cannot be 'ruled-out'. As a result, 50 babies will receive antibiotics unnecessarily, for every one baby who is later proven to have infection. This can cause harm by increasing the risk of antimicrobial resistant infections, necrotising enterocolitis and later life diseases such as asthma.
Critically, it is difficult to quantify the effects of unnecessary antibiotic exposure on an individual, rather than population basis. Here, we propose to study those babies who were treated with antibiotics, but never proven to have infection. At recruitment, we will document their immune response and microbiome (via a stool test) and then assess how this changes over time. We will record routine blood tests, measures of health and nutrition and follow these to patient discharge. We will also review follow-on outpatient appointments that record developmental and nutritional status upto 1 year. This will provide a longitudinal analysis culture-negative infants, those infrequently targeted in research.
Our work will lead to an electronic dashboard, that charts indices to inform clinicians on the effects of unnecessary antibiotic use. We will use survey clinicians on their understanding of digital feedback tools to inform antimicrobial decision-making.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
26/EE/0133
Date of REC Opinion
22 May 2026
REC opinion
Further Information Favourable Opinion