Neonatal Hyperbilirubinemia Clinical Trial
Official title:
Neonatal, Clinical and Neurodevelopmental Outcome of Neonates Hospitalized for Neonatal Hyperbilirubinemia Reaching Exchange Transfusion Threshold in a Remote Setting Along the Thai-Myanmar Border
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.
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.
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