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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03353051 |
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Date of registration:
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20/07/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Iron and Infection: Neonatal Nutritional Immunity
NeoInnate |
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Scientific title:
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Iron and Infection: Neonatal Nutritional Immunity (NeoInnate Study) |
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Date of first enrolment:
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July 25, 2017 |
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Target sample size:
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430 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03353051 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Gambia
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Contacts
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Name:
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Carla Cerami, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical Council Unit the Gambia |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
28 Days
Gender:
All
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Health Condition(s) or Problem(s) studied
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Neonatal Infection
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Nutritional Anemia
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Intervention(s)
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Other: Observational study
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Primary Outcome(s)
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serum iron
[Time Frame: at 7 days after birth]
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Secondary Outcome(s)
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TSAT (%) and heme iron (mg/dL)
[Time Frame: at 6 hours after birth]
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microorganisms that are common causes of neonatal sepsis
[Time Frame: At 0, 6 and 24 hours after birth]
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Iron (ug/dL), TSAT (%) and heme iron (mg/dL) regulated regulation in FT neonates
[Time Frame: 7 days after birth]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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