Study on Newborn Babies With a Yellow Skin Color (Neonatal Jaundice Study)
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|ClinicalTrials.gov Identifier: NCT02361788|
Recruitment Status : Active, not recruiting
First Posted : February 12, 2015
Last Update Posted : October 2, 2018
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.
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.
- 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
The study will conduct an exhaustive prospective descriptive study, all eligible newborns will be enrolled after obtaining the informed consent from their mothers. During pregnancy and delivery we will collect clinical data about the mother. At birth we will take umbilical cord blood (9 ml) to test for different causes of neonatal hyperbilirubinemia. In the first week of life we plan 4 moments to measure the bilirubin and hematocrit level (0.05 ml), weight and ask questions about feeding and other practices. Based on the bilirubin results we will determine whether the neonate needs phototherapy. After the first week we weekly follow-up will be conducted and in case of visible jaundice we will measure the bilirubin level. If the neonate is still jaundiced after the age of 21 days we will further investigate the cause. In the infant period, until the age of one year, we plan to have monthly follow-up to assess the health and growth of the child and at the age of 3, 6 and 12 months we will do a neurodevelopmental test.
An improved understanding of the pathological processes contributing to the development of neonatal hyperbilirubinemia is needed in order to to identify neonates at risk and develop improved management.
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||1710 participants|
|Official Title:||A Prospective Cohort Study on the Etiology of Neonatal Hyperbilirubinemia in a Migrant and Refugee Population on the Thai-Myanmar Border|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
- Causes of development of neonatal hyperbilirubinemia [ Time Frame: 1 year ]Establish the causes contributing to the development of neonatal hyperbilirubinemia in this population, including a detailed description of the clinical course of neonates with neonatal hyperbilirubinemia.
- Incidence of neonatal hyperbilirubinemia [ Time Frame: 1 year ]
- Clinical and biochemical risk factors for the development of neonatal hyperbilirubinemia [ Time Frame: 1 year ]
- Incidence of prolonged jaundice [ Time Frame: 1 year ]
- Neurodevelopmental outcome [ Time Frame: 6 month ]
- Body composition at birth, 1, 2 and 3 months of age [ Time Frame: 3 month ]
- Incidence of anaemia and illness episodes [ Time Frame: 1 year ]
- Incidence of helminthic infection [ Time Frame: 1 year ]
- Knowledge level and misbeliefs on neonatal hyperbilirubinemia [ Time Frame: approximately 1 year ]
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): NCT02361788
|Shoklo Malaria Research Unit|
|Mae Sot, Tak, Thailand|
|Principal Investigator:||François Nosten, Prof.||Shoklo Malaria Research Unit|