Study on Newborn Babies With a Yellow Skin Color (Neonatal Jaundice Study)
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|ClinicalTrials.gov Identifier: NCT02361788|
Recruitment Status : Completed
First Posted : February 12, 2015
Last Update Posted : January 17, 2023
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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.
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
Research design: 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|
|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|
|Actual Study Start Date :||January 28, 2015|
|Actual Primary Completion Date :||June 12, 2016|
|Actual Study Completion Date :||May 18, 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 ]
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
Over the course of a one year period, the mothers of neonates (estimated gestation ≥ 28 weeks) who meet the inclusion criteria and none of the exclusion criteria will be asked to participate in this study.
Based on previous experience, assuming that most mothers will agree to participate in the study and 15% of the included neonates will be lost before completion of the study, we will include approximately 1887 neonates. With an estimated proportion of neonatal hyperbilirubinemia of 18%, 340 of 1887 neonates will develop neonatal hyperbilirubinemia. Other prospective studies had numbers of neonates with neonatal hyperbilirubinemia ranging from 21 to 624.
- Written or thumb print informed consent from the mother during pregnancy
- Neonates who are born to mothers who followed antenatal care at SMRU antenatal clinics
- Neonates who are born in a SMRU clinic OR neonates who are born outside SMRU but visit a SMRU clinic within 48 hours after birth OR neonates who are born outside SMRU and present with neonatal jaundice at any moment in the first 8 days
- No written or thumb print informed consent from the mother during pregnancy
- Neonates who are born to mothers who did not follow antenatal care
- Neonates < 28 weeks gestation
- Neonate born outside SMRU and present > 48 hours after delivery without jaundice
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|
|Responsible Party:||University of Oxford|
|Other Study ID Numbers:||
|First Posted:||February 12, 2015 Key Record Dates|
|Last Update Posted:||January 17, 2023|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Volunteers' data and results of blood sample analysis stored in our database may be shared with other researchers to use in the future. However, the other researchers will not be given any information that could identify the subject.|
Clinical Study Report (CSR)
Infant, Newborn, Diseases