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

NCT02361788 | Completed

• 1 other identifier: SMRU 1307
• Study Type: observational
• Target: 1,710
• Locations: 1 country
• Sites: 1

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 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

Keywords

neonatal hyperbilirubinemia; etiology; incidence; risk factors

Outcome Measures

Primary Outcomes (1)

• Causes of development of neonatal hyperbilirubinemia

  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.

  1 year

Secondary Outcomes (1)

• Incidence of neonatal hyperbilirubinemia

  1 year

Other Outcomes (7)

• Clinical and biochemical risk factors for the development of neonatal hyperbilirubinemia

  1 year

• Incidence of prolonged jaundice

  1 year

• Neurodevelopmental outcome

  6 month

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Shoklo Malaria Research Unit

Mae Sot, Changwat Tak, Thailand

Location

Related Publications (1)

• Thielemans L, Trip-Hoving M, Bancone G, Turner C, Simpson JA, Hanboonkunupakarn B, van Hensbroek MB, van Rheenen P, Paw MK, Nosten F, McGready R, Carrara VI. Neonatal Hyperbilirubinemia in a Marginalized Population on the Thai-Myanmar Border: a study protocol. BMC Pediatr. 2017 Jan 21;17(1):32. doi: 10.1186/s12887-017-0798-8.

  PMID: 28109243 DERIVED

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• François Nosten, Prof.

  Shoklo Malaria Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2014
• First Posted: February 12, 2015
• Study Start: January 28, 2015
• Primary Completion: June 12, 2016
• Study Completion: May 18, 2019
• Last Updated: January 17, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

TH (1)