Study on Newborn Babies With a Yellow Skin Color (Neonatal Jaundice Study)
Study Purpose
Background: Neonatal hyperbilirubinemia is the most common reason for admission in the neonatal period (first month of life) worldwide and at SMRU. The skin of the newborn baby becomes jaundiced, which is caused by a high level of bilirubin in the blood. In some neonates the level of bilirubin increases to a level that can cause braindamage or even death. There are different causes known that can lead to higher levels of bilirubin, for example G6PD deficiency and prematurity. In case of neonatal hyperbilirubinemia the neonate needs to be treated with phototherapy (blue light therapy). If there is prolonged jaundice (≥ 21 days), further investigations needs to be done. Objectives: Primary objective: To determine the etiology of neonatal hyperbilirubinemia in neonates with a gestational age of ≥ 28 weeks from the refugee and migrant population, on the Thai-Myanmar border. Secondary objective:
- - Establishing the incidence of neonatal hyperbilirubinemia.
- - Determine the risk factors for the development of neonatal hyperbilirubinemia.
- - Determine the incidence of prolonged neonatal jaundice.
- - Determine the neurodevelopmental outcome, at the age of 6 and 12 months.
- - Determine the body composition, using air-displacement plethysmography, at birth, 1, 2 and 3 months of age.
- - Determine the incidence of anaemia and illness episodes during the first year of life.
- - Determine the incidence of helminthic infection at the age of one year.
- - Assess the knowledge level and misbeliefs on neonatal hyperbilirubinemia among the mothers and SMRU health care staff.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
Yes |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
Eligible Ages | N/A and Over |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT02361788 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
University of Oxford |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
François Nosten, Prof. |
Principal Investigator Affiliation | Shoklo Malaria Research Unit |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Active, not recruiting |
Countries | Thailand |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Neonatal Hyperbilirubinemia |
Contact a Trial Team
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