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
Verified date | June 2017 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 78 |
Est. completion date | March 31, 2017 |
Est. primary completion date | March 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 28 Weeks and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Oxford |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Function Scores | The odds ratio of visual function scores between survivors of NH reaching exchange transfusion threshold and those with moderate NH | 8 years | |
Primary | Neurodevelopmental scores | The odds ratio of neurodevelopmental scores between survivors of NH reaching exchange transfusion threshold and those with moderate NH | 8 years | |
Primary | Clinical status | The clinical status between survivors of NH reaching exchange transfusion threshold and those with moderate NH | 8 years | |
Secondary | Mortality rate | The mortality rate among neonates with NH reaching exchange transfusion threshold | 8 years | |
Secondary | Proportion of neonates with ABE | The proportion of neonates with ABE among those with NH reaching exchange transfusion threshold | 8 years | |
Secondary | Proportion of neonates with G6PD deficiency | The proportion of neonates with G6PD deficiency present among neonates with NH reaching exchange transfusion threshold | 8 years | |
Secondary | Proportion of neonates with ABO incompatibility | The proportion of neonates with ABO incompatibility present among neonates with NH reaching exchange transfusion threshold | 8 years | |
Secondary | Proportion of neonates with polycythaemia | The proportion of neonates with polycythaemia present among neonates with NH reaching exchange transfusion threshold | 8 years | |
Secondary | Proportion of neonates with birth trauma | The proportion of neonates with birth trauma present among neonates with NH reaching exchange transfusion threshold | 8 years | |
Secondary | Proportion of neonatal sepsis | The proportion of neonatal sepsis present among neonates with NH reaching exchange transfusion threshold | 8 years | |
Secondary | Proportion of neonates with prematurity | Proportion of neonates with prematurity present among neonates with NH reaching exchange transfusion threshold | 8 years |
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)
|