Clinical and Developmental Outcomes of Babies Who Became Yellow in the First Month of Life
Clinical and Developmental Outcomes of Babies Who Became Yellow in the First Month of Life
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.
Inclusion Criteria:

 Cases

 Liveborn, singleton, ≥28 weeks gestation, hospitalized at SMRU SCBU presenting one or more
 of the following criteria:

 -  Two consecutive SBR measures above the exchange transfusion threshold of the
 phototherapy charts for gestational age

 -  SBR levels rising > 8.5 µmol/L per hour

 -  One or more neurological signs compatible with ABE in the absence of other known
 neurological condition and in the presence of confirmed NH

 Controls

 Liveborn singleton, ≥28 weeks gestation, hospitalized at SMRU SCBU presenting all of the
 following criteria:

 -  At least one SBR between the moderate and the severe threshold of the phototherapy
 charts for gestational age

 -  No SBR above the severe threshold at any time point

 -  No reported abnormal neurological signs (i.e. convulsions, abnormal cry or tone)

 Each case who has been discharged alive from the SCBU will be matched to one control from
 the same clinic, sex, gestational age, season of birth and hospitalized within the same
 month and the clinical and neurodevelopment of both children will be conducted once.

 Exclusion Criteria:

 -  Stillborn

 -  Twins

 -  Liveborn < 28 weeks gestation

 -  Major congenital malformation

 -  Liveborn singleton, ≥28 weeks gestation, hospitalized outside SMRU SCBU

 -  Liveborn singleton, ≥28 weeks gestation, hospitalized at SMRU SCBU without SBR done or
 with all SBR below the moderate threshold of the phototherapy charts for gestational
 age