Status:
COMPLETED
Iron and Infection: Neonatal Nutritional Immunity
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
University of Oxford
Department of State for Health and Social Welfare, The Gambia
Conditions:
Neonatal Infection
Nutritional Anemia
Eligibility:
All Genders
5-28 years
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 ...
Detailed Description
The epicentres of neonatal death worldwide are West and Central Africa, with an estimated 35 deaths per 1000 births. Neonatal infection is the third largest cause of death in children under five world...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 25 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 3 2019
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT03353051
Start Date
July 25 2017
End Date
April 3 2019
Last Update
February 24 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Serrekunda General Hospital
Kanifing, Near Banjul, The Gambia