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

NCT02361788 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1710

Last updated 2023-01-17

No results posted yet for this study

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 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.

Conditions

  • Neonatal Hyperbilirubinemia

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • François Nosten, Prof. · Shoklo Malaria Research Unit

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-28
Primary Completion
2016-06-12
Completion
2019-05-18

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02361788 on ClinicalTrials.gov