Neonatal HyperbilirubinemiaNCT02927093
Clinical and Developmental Outcomes of Babies Who Became Yellow in the First Month of Life
An observational study of Neonatal Hyperbilirubinemia, run by University of Oxford.
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… Read more about this study
- Who is it for?
- Ages 28 weeks and older
- Conditions the study is for
- Neonatal Hyperbilirubinemia
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to 31 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Liveborn, singleton, ≥28 weeks gestation, hospitalized at SMRU SCBU, from 1st January 2009 to 31st December 2014 will be included.
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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
About this study
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.
Read the detailed 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.
- Conditions
- Neonatal Hyperbilirubinemia
- Medical subject headings
- Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | neonates with NH reaching exchange transfusion threshold | |
| Control | neonates with NH within moderate threshold of the phototherapy charts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Function Scores
The odds ratio of visual function scores between survivors of NH reaching exchange transfusion threshold and those with moderate NH
Measured: 8 years
Neurodevelopmental scores
The odds ratio of neurodevelopmental scores between survivors of NH reaching exchange transfusion threshold and those with moderate NH
Measured: 8 years
Clinical status
The clinical status between survivors of NH reaching exchange transfusion threshold and those with moderate NH
Measured: 8 years
Secondary outcomes (8)
Mortality rate
The mortality rate among neonates with NH reaching exchange transfusion threshold
Measured: 8 years
Proportion of neonates with ABE
The proportion of neonates with ABE among those with NH reaching exchange transfusion threshold
Measured: 8 years
Proportion of neonates with G6PD deficiency
The proportion of neonates with G6PD deficiency present among neonates with NH reaching exchange transfusion threshold
Measured: 8 years
Proportion of neonates with ABO incompatibility
The proportion of neonates with ABO incompatibility present among neonates with NH reaching exchange transfusion threshold
Measured: 8 years
Proportion of neonates with polycythaemia
The proportion of neonates with polycythaemia present among neonates with NH reaching exchange transfusion threshold
Measured: 8 years
Proportion of neonates with birth trauma
The proportion of neonates with birth trauma present among neonates with NH reaching exchange transfusion threshold
Measured: 8 years
Proportion of neonatal sepsis
The proportion of neonatal sepsis present among neonates with NH reaching exchange transfusion threshold
Measured: 8 years
Proportion of neonates with prematurity
Proportion of neonates with prematurity present among neonates with NH reaching exchange transfusion threshold
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal HyperbilirubinemiaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927093
- Sponsor's protocol ID
- SMRU 1605
- Status last verified
- Jun 2017
- First submitted
- 5 Oct 2016
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The data will be stored in the database and may be shared with other researchers in the future, however, data will be anonymous and the researchers will not know the participant identity.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02927093
- Acronym / sponsor ID
- SMRU 1605
- Conditions
- Neonatal Hyperbilirubinemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –neonates with NH reaching exchange transfusion threshold |
| Control | – | –neonates with NH within moderate threshold of the phototherapy charts |
Who may qualify
- Ages
- 28 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Liveborn, singleton, ≥28 weeks gestation, hospitalized at SMRU SCBU, from 1st January 2009 to 31st December 2014 will be included.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- Stillborn
- Twins
- Liveborn < 28 weeks gestation
- Major congenital malformation
- Liveborn singleton, ≥28 weeks gestation, hospitalized outside SMRU SCBU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Function Scores
Time frame: 8 years
The odds ratio of visual function scores between survivors of NH reaching exchange transfusion threshold and those with moderate NH
Neurodevelopmental scores
Time frame: 8 years
The odds ratio of neurodevelopmental scores between survivors of NH reaching exchange transfusion threshold and those with moderate NH
Clinical status
Time frame: 8 years
The clinical status between survivors of NH reaching exchange transfusion threshold and those with moderate NH
8 secondary outcomes
Mortality rate
Time frame: 8 years
Proportion of neonates with ABE
Time frame: 8 years
Proportion of neonates with G6PD deficiency
Time frame: 8 years
Proportion of neonates with ABO incompatibility
Time frame: 8 years
Proportion of neonates with polycythaemia
Time frame: 8 years
Proportion of neonates with birth trauma
Time frame: 8 years
Proportion of neonatal sepsis
Time frame: 8 years
Proportion of neonates with prematurity
Time frame: 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Individual participant dataSharing planned: Yes. The data will be stored in the database and may be shared with other researchers in the future, however, data will be anonymous and the researchers will not know the participant identity.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Hyperbilirubinemia, run by University of Oxford.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Function Scores (time frame: 8 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2017.