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临床试验/NCT02361788
NCT02361788已完成不适用

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

University of Oxford1 个研究点 分布在 1 个国家目标入组 1,710 人开始时间: 2015年1月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,710
试验地点
1
主要终点
Causes of development of neonatal hyperbilirubinemia

研究概览

简要总结

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

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Causes of development of neonatal hyperbilirubinemia

时间窗: 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.

次要结局

  • Incidence of neonatal hyperbilirubinemia(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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