A feasibility study looking at complement immunity in extreme preterms.

  • Research type

    Research Study

  • Full title

    A feasibility study looking at the impact of complement immunity in extremely preterm neonates.

  • IRAS ID

    161844

  • Contact name

    Axel Heep

  • Contact email

    axel.heep@nbt.nhs.uk

  • Sponsor organisation

    North Bristol NHS Trust

  • Duration of Study in the UK

    1 years, 0 months, 1 days

  • Research summary

    Despite improvements in medical care preterm infants born more than 10 weeks early remain at high risk of significant infection, which impacts their chance of survival and long-term health.

    The “complement system” part of the immune system and forms the first line defence against infection. Studies have described reduced quantity and function of complement components in healthy newborn infants but none have looked exclusively at extremely preterm infants.

    We aim to understand the quantity and function of complement system components in extremely premature infants for the first time.

    Specifically our research will look at whether:
    1. Quantity of complement components is related to gestational age
    2. Low level complement increases the risk of severe infection in extremely preterm infants
    3. Prolonged activation of complement relates to the development of “Retinopathy of Prematurity” (ROP), a problem exclusive to preterm infants causing visual problems and blindness.

    Two blood samples will be required from preterm babies; one from the umbilical cord and placenta after separation from the baby at birth and one alongside regular routine blood testing at 30 weeks gestational age. A control group of healthy term infants will have a single sample taken as above at birth.

    We will use the outcomes from this proof of concept work to design a National institute of Health Research (NIHR) feasibility study. Ultimately, this research will be taken to the bedside and provide better clinical outcomes for extremely preterm infants.

    We are looking to identify complement as a marker for increased susceptibility to infection and ROP; allowing more informed treatment decisions and potential preventative measures for many of the complications that arise in preterm infants.

    Our results may lead to future research establishing complement supplementation as routine treatment for preterm infants to prevent infection, reduce need for antibiotics and improve health outcomes, particularly visual problems.

  • REC name

    West of Scotland REC 3

  • REC reference

    15/WS/0101

  • Date of REC Opinion

    23 Jun 2015

  • REC opinion

    Further Information Favourable Opinion