Clinical Trial: Study on Newborn Babies With a Yellow Skin Color (Neonatal Jaundice Study)

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Observational

Official Title: A Prospective Cohort Study on the Etiology of Neonatal Hyperbilirubinemia in a Migrant and Refugee Population on the Thai-Myanmar Border

Brief Summary:

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 in
  

  Detailed Summary:

  PROCEDURES DURING PREGNANCY

  During the first antenatal care visit the mother will have a gestational dating ultrasound to determine the accurate gestational age. During all antenatal care visits information about the mother will be collected as part of standard obstetric care:

  • Ethnicity
  • Age

  • Medical history

    • Blood transfusion in history
    • Chronic diseases

  • Obstetric history

    • Parity and gravida
    • Previous neonatal deaths and reason of death
    • Previous preterm delivery
    • Previous child with neonatal hyperbilirubinemia

  • Pregnancy

    • Gestational dating ultrasound
    • Obstetric problems
    • Malaria and morbidity episodes during pregnancy
    • BMI, MUAC and weightgain

    • Laboratory results

      • Hepatitis B status*
      • HIV status*
      • Syphilis serology*
      • G6PD status
      • 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.