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Trial record 1 of 1 for:    NCT02361788
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Study on Newborn Babies With a Yellow Skin Color (Neonatal Jaundice Study)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2015 by University of Oxford.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT02361788
First received: September 1, 2014
Last updated: March 2, 2015
Last verified: February 2015
  Purpose

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.


Condition
Neonatal Hyperbilirubinemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study on the Etiology of Neonatal Hyperbilirubinemia in a Migrant and Refugee Population on the Thai-Myanmar Border

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Incidence of neonatal hyperbilirubinemia [ Time Frame: 1 year ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 1887
Study Start Date: February 2015
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02361788

Contacts
Contact: Dr. Margreet Trip-Hoving, MD margreet@shoklo-unit.com

Locations
Thailand
Shoklo Malaria Research Unit Recruiting
Mae Sot, Tak, Thailand
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: François Nosten, Prof. Shoklo Malaria Research Unit
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02361788     History of Changes
Other Study ID Numbers: SMRU 1307
Study First Received: September 1, 2014
Last Updated: March 2, 2015

Keywords provided by University of Oxford:
neonatal hyperbilirubinemia
etiology
incidence
risk factors

Additional relevant MeSH terms:
Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Pathologic Processes
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on June 27, 2017