Iron and Infection: Neonatal Nutritional Immunity
NeoInnate
1 other identifier
observational
430
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2017
CompletedStudy Start
First participant enrolled
July 25, 2017
CompletedFirst Posted
Study publicly available on registry
November 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 3, 2019
CompletedFebruary 24, 2020
February 1, 2020
1.3 years
July 20, 2017
February 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
serum iron
will be measured using a COBAS INTEGRA 400 plus clinical chemistry analyzer
at 7 days after birth
Secondary Outcomes (3)
TSAT (%) and heme iron (mg/dL)
at 6 hours after birth
Iron (ug/dL), TSAT (%) and heme iron (mg/dL) regulated regulation in FT neonates
7 days after birth
microorganisms that are common causes of neonatal sepsis
At 0, 6 and 24 hours after birth
Study Arms (6)
Group A: other - observational study
neonates ≥2000-\<2500g and born with a gestation age \<37 weeks.
Group B: other- observational study
Group B will contain neonates \>2500g and born with a gestation age \<37 weeks.
Group C: other - observational study
Group C will contain neonates ≥2000-\<2500g but with a gestation age \>37 weeks.
Group D1:other - observational study
Neonate \>2500g and born with a gestation age \>37 weeks. These neonates will donate blood at 6-24hrs and at 30-48hrs.
Group D2: other - observational study
Neonate \>2500g and born with a gestation age \>37 weeks. These neonates will donate blood at 6-24hrs and at 42-60hrs
Group D3: other - observational study
Neonate \>2500g and born with a gestation age \>37 weeks. These neonates will donate blood at 6-24hrs and at 144-192hrs.
Interventions
Observational study
Eligibility Criteria
All neonates will be born at Serrekunda Hospital, The Gambia. New Ballard score is only measure used to evaluate gestational age Preterm neonates with Low Birth Weight (PTB with LBW) (Group A): Neonates will not be recruited directly into this group. These medical stable neonates will weigh \<2500g and also be \<37 weeks of gestational age. Preterm (PTB) neonates (Group B): Medical stable neonates between \>32 and \<37 weeks' gestational age. PTB neonates will weigh \>2500g. Low Birth Weight (LBW) neonates (Group C): Medical stable neonates with weight equal to or \>2000g and \<2500g. LBW neonates will have a gestational age of \>32 weeks. Full Term (FT) neonates (Group D1-D3): All healthy FT neonates will weigh ≥2500g with gestational age ≥37 weeks.
You may qualify if:
- Low Birth Weight (LBW) neonates:
- Medical stable neonates
- Neonatal weight ≥2000g and \<2500g
- Born at Serrekunda Hospital
- Gestational age will be \>37 weeks.
- Born to mothers at least 18 years of age
- Preterm neonates with Low Birth Weight (PTB+LBW):
- Medical stable neonates
- Born at Serrekunda Hospital
- Neonates weighing \<2500g and \<37 weeks of gestational age.
- Born to mothers at least 18 years of age
- Preterm (PTB) neonates:
- Medical stable neonates
- \>32 and \<37 weeks' gestational age
- Born at Serrekunda Hospital
- +8 more criteria
You may not qualify if:
- Major congenital malformations
- Severe birth asphyxia
- Children from multiple births
- Medication (i.e. prophylactic antibiotics) given to neonate before first neonatal venous blood draw
- Neonates born via Breech, Vacuum or C section
- Neonates with infection/illness (information gained from venous bleed) will no longer be required to give future samples if originally required
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Serrekunda General Hospital
Kanifing, Near Banjul, The Gambia
Related Publications (3)
Cross JH, Jarjou O, Mohammed NI, Gomez SR, Touray BJB, Kessler NJ, Prentice AM, Cerami C. Iron homeostasis in full-term, normal birthweight Gambian neonates over the first week of life. Sci Rep. 2023 Jun 26;13(1):10349. doi: 10.1038/s41598-023-34592-z.
PMID: 37365154DERIVEDCross JH, Jarjou O, Mohammed NI, Rayment Gomez S, Touray BJB, Prentice AM, Cerami C. Early postnatal hypoferremia in low birthweight and preterm babies: A prospective cohort study in hospital-delivered Gambian neonates. EBioMedicine. 2020 Feb;52:102613. doi: 10.1016/j.ebiom.2019.102613. Epub 2020 Jan 22.
PMID: 31981986DERIVEDCross JH, Jarjou O, Mohammed NI, Prentice AM, Cerami C. Neonatal iron distribution and infection susceptibility in full term, preterm and low birthweight babies in urban Gambia: study protocol for an observational study. Gates Open Res. 2019 Oct 15;3:1469. doi: 10.12688/gatesopenres.12963.2. eCollection 2019.
PMID: 31588425DERIVED
Biospecimen
Serum will be kept for follow up analysis if further iron and inflammation parameters require quantification. G6PD deficiency and sickle cell disease are confounders in the bacterial growth assay. G6PD deficiency genetic test will be performed on whole blood. Sickle cell will be assessed by PCR. Samples will be saved for additional possible DNA analysis.
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carla Cerami, MD, PhD
Medical Council Unit the Gambia
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2017
First Posted
November 27, 2017
Study Start
July 25, 2017
Primary Completion
November 21, 2018
Study Completion
April 3, 2019
Last Updated
February 24, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share