Clinical Trials Logo

Clinical Trial Summary

The Shoklo Malaria Research Unit (SMRU) provides care to refugees and migrant populations along the Thai-Burma border since 1986. Services include antenatal and birthing care, with 2,500 births per year and Special Care Baby Units (SCBU) set up in 2008; all medical records including clinical and laboratory data are archived. The treatment of neonatal jaundice is based on treatment thresholds adapted from the neonatal jaundice guidelines, published by the Royal College of Obstetricians and Gynaecologists, UK. Total serum bilirubin (SBR) is done at regular intervals to monitor neonatal hyperbilirubinemia (NH) evolution, following SMRU guidelines. The SCBU have been set up to provide intensive care for neonates in a resource constrained setting and don't have equipment for assisted ventilation other than oxygen therapy. Neonates presenting with high serum bilirubin levels and/or clinical signs of acute bilirubin encephalopathy (ABE) cannot receive exchange transfusion on site and have to be referred to the Thai general hospital one hour drive from the clinics; and, for those neonates surviving, there has not been a systematic follow-up of their growth and neurodevelopment.

The study will consist of a matched case-control series and a retrospective review of SCBU charts of neonates with NH reaching exchange transfusion threshold. The SCBU database will be searched for neonates born at ≥ 28 weeks of gestation hospitalized for phototherapy between January 2009 and December 2014; charts will be manually researched to identify study participants which will be classified as NH reaching exchange transfusion threshold (cases) or as NH within moderate threshold (controls). Additionally neurological signs compatible with ABE will be searched in the clinical notes and coded as present/absent. Cases discharged alive from the SCBU will be traced back to evaluate their clinical and neurocognitive long term outcome. Each case will be matched with a moderate NH control from the same clinic, sex, gestational age and season of birth and hospitalized within the same month.

The results of this study will help to improving the clinical care during the neonatal period and to developing a guideline for a better follow-up of children with NH reaching exchange transfusion threshold.


Clinical Trial Description

The study will consist of a matched case-control series and a retrospective review of SCBU charts of neonates with NH reaching exchange transfusion threshold.

The SCBU database will be searched for neonates born at ≥ 28 weeks of gestation hospitalized for phototherapy between January 2009 and December 2014. The SCBU charts of these neonates will be manually researched to identify study participants which will be classified as NH reaching exchange transfusion threshold (cases) or as NH within moderate threshold (controls). Additionally neurological signs compatible with ABE that would likely be reported by the clinical staff will be searched in the clinical notes and coded as present/absent; those signs are: sleepiness, irritability, apnea, convulsions, abnormal position/tone, and abnormal cry. Those charts will be included into the cases.

Cases discharged alive from the SCBU will be traced back to evaluate their clinical and neurocognitive long term outcome. Each case will be matched with a moderate NH control from the same clinic, sex, gestational age and season of birth and hospitalized within the same month.

Both will be examined clinically and findings reported on a standardized forms, their visual function will be tested using the Cardiff acuity and contrast cards and their neurocognitive development will be assessed using the Griffiths Mental Development Scales-Extended revised.

Maternal demographics and additional birth variables (i.e. birth asphyxia, type of delivery, breastfeeding) will be extracted from the antenatal care database and added to the selected cases; laboratory results (G6PD deficiency, ABO incompatibility, haematocrit) are stored in the SCBU database and will be retrieved. The general characteristics, the trajectory of SBR, and the neonatal outcome will be described. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02927093
Study type Observational
Source University of Oxford
Contact
Status Completed
Phase N/A
Start date October 2016
Completion date March 31, 2017

See also
  Status Clinical Trial Phase
Recruiting NCT06186349 - The Effect and Mechanism of Gene Variation on Neonatal Hyperbilirubinemia
Recruiting NCT04369313 - Effect of DCC on Neonatal Jaundice and Blood Gas Analysis in Infants Born to GDM Mothers N/A
Not yet recruiting NCT04585828 - Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy N/A
Unknown status NCT01340339 - Reverse Phototherapy With Super Light-emitting Diode(Super-LED) for Hyperbilirubinemia in Term and Late Preterm Infants Phase 4
Completed NCT02033096 - Observational Follow-up of Participants From Clinical Trial 64,185-202 (NCT00850993)
Recruiting NCT04218318 - Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn N/A
Active, not recruiting NCT02602301 - The Effect of Intravenous Oxytocin Infusion Using Different Diluents on Neonatal Bilirubin & Sodium Levels Phase 4
Completed NCT00801619 - Bilicurves: Using Information Technology to Improve the Management of Neonatal Hyperbilirubinemia N/A
Active, not recruiting NCT05343403 - Parental Participation on the Neonatal Ward - the neoPARTNER Study
Completed NCT03880591 - Neonatal Hyperbilirubinaemia in the Democratic Republic of Congo
Completed NCT01599611 - Follow-up of Extreme Neonatal Hyperbilirubinemia in 5-10 Year Old Children: a Danish Population Based Study N/A
Recruiting NCT06399146 - Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Population in Botswana N/A
Completed NCT06018012 - MRA and ABR as Early Predictors of Bilirubin-Induced Neurologic Dysfunction in Full-term Jaundiced Neonates
Completed NCT03536078 - Home Phototherapy for Term Newborns With Icterus N/A
Withdrawn NCT00917007 - Measurement of Carboxyhemoglobin by Gas Chromatography as an Index of Hemolysis
Recruiting NCT00154960 - Establishing Novel Detection Techniques for Various Genetic-Related Diseases by Applying DHPLC Platform. N/A
Recruiting NCT02594904 - Efficacy of Yinzhihuang Oral Liquid on Indirect Bilirubin of Neonates With Glucose-6-phosphate Dehydrogenase Deficiency Phase 4
Completed NCT01746511 - Glycerin Suppositories to Reduce Jaundice in Premature Infants N/A
Completed NCT01470820 - Dose-response Relationship of Phototherapy for Hyperbilirubinaemia Using Diodes: is There a "Saturation Point" N/A
Completed NCT02361788 - Study on Newborn Babies With a Yellow Skin Color (Neonatal Jaundice Study)