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Iron and Infection: Neonatal Nutritional Immunity (NeoInnate)

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ClinicalTrials.gov Identifier: NCT03353051
Recruitment Status : Active, not recruiting
First Posted : November 27, 2017
Last Update Posted : January 4, 2019
Sponsor:
Collaborators:
University of Oxford
Department of State for Health and Social Welfare, The Gambia
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

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.


Condition or disease Intervention/treatment
Neonatal Infection Nutritional Anemia Other: Observational study

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Iron and Infection: Neonatal Nutritional Immunity (NeoInnate Study)
Actual Study Start Date : July 25, 2017
Actual Primary Completion Date : November 21, 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Group/Cohort Intervention/treatment
Group A: other - observational study
neonates ≥2000-<2500g and born with a gestation age <37 weeks.
Other: Observational study
Observational study

Group B: other- observational study
Group B will contain neonates >2500g and born with a gestation age <37 weeks.
Other: Observational study
Observational study

Group C: other - observational study
Group C will contain neonates ≥2000-<2500g but with a gestation age >37 weeks.
Other: Observational study
Observational study

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.
Other: Observational study
Observational study

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
Other: Observational study
Observational study

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.
Other: Observational study
Observational study




Primary Outcome Measures :
  1. serum iron [ Time Frame: at 7 days after birth ]
    will be measured using a COBAS INTEGRA 400 plus clinical chemistry analyzer


Secondary Outcome Measures :
  1. TSAT (%) and heme iron (mg/dL) [ Time Frame: at 6 hours after birth ]
    During the neonatal transition period in PTB and LBW neonates and FT babies in cord blood and at 6 hours after birth. TSAT and heme iron will be measured using a using a COBAS INTEGRA 400 plus clinical chemistry analyzer .

  2. Iron (ug/dL), TSAT (%) and heme iron (mg/dL) regulated regulation in FT neonates [ Time Frame: 7 days after birth ]
    During the first 7 days of life. Iron, TSAT and heme iron will be measured using a using a COBAS INTEGRA 400 plus clinical chemistry analyzer

  3. microorganisms that are common causes of neonatal sepsis [ Time Frame: At 0, 6 and 24 hours after birth ]
    Does sera from PTB and LBW neonates after birth support more ex-vivo growth of microorganisms that are common causes of neonatal sepsis in Africa and The Gambia (Staphylococcus aureus, Klebsiella pneumoniae, Escherichia coli, Group B Streptococcus, Streptococcus pneumoniae and Salmonella Tyhpimurium) than sera from FT neonates


Biospecimen Retention:   Samples With DNA

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.



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

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
  • PTB neonates will weigh more than 2500g
  • Born to mothers at least 18 years of age

Full Term (FT) neonates:

  • Healthy neonates
  • Born at Serrekunda Hospital
  • FT neonates will weigh ≥2500g
  • Gestational age ≥37 weeks
  • Born to mothers at least 18 years of age

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353051


Locations
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Gambia
Serrekunda General Hospital
Kanifing, Near Banjul, Gambia
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
University of Oxford
Department of State for Health and Social Welfare, The Gambia
Investigators
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Principal Investigator: Carla Cerami, MD, PhD Medical Council Unit the Gambia

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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03353051     History of Changes
Other Study ID Numbers: SCC1525
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases