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Iron and Infection: Neonatal Nutritional Immunity

NCT03353051 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 430

Last updated 2020-02-24

No results posted yet for this study

Summary

The motivation for this study was produced from our preliminary data, which showed that during the first 96 hours of life a full-term neonate will actively reduce the overall serum iron concentration of their blood and the transferrin saturation decreases rapidly from 45% in cord blood to \~20% by six hours post-delivery.

The Investigators hypothesise that this active sequestration of iron, which results in hypoferremia, is done in an effort to limit susceptibility to infection, a process referred to as nutritional immunity.

Currently, little is known about iron regulation and iron homeostasis during the first week of life and even less is known about the comparisons of nutritional immunity between full term, preterm and low birth weight neonates. Additionally, limited research has been conducted on the impact of these processes on bacterial pathogens.

In an effort to study the neonatal nutritional immunity and its role in neonatal susceptibility to infection, The investigator will conduct an observational study in full-term, preterm and low birth weight vaginally-delivered neonates born at Serrekunda General Hospital, The Gambia.

The investigators will fully characterise and quantify nutritional immunity during the early neonatal period and the investogators will assess how this impacts bacterial growth. Study sensitisation will occur at the antenatal clinic, during the mother's second trimester of pregnancy. Mothers will be consented and enrolled at delivery. Blood samples will be collected once from the umbilical cord and at serial time points from the neonates over the first week of life.

Conditions

  • Neonatal Infection
  • Nutritional Anemia

Interventions

OTHER

Observational study

Observational study

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • Department of State for Health and Social Welfare, The Gambia

    collaborator OTHER_GOV

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Carla Cerami, MD, PhD · Medical Council Unit the Gambia

Eligibility

Min Age
5 Minutes
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-25
Primary Completion
2018-11-21
Completion
2019-04-03

Countries

  • The Gambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03353051 on ClinicalTrials.gov