KernicterusNCT02713464
Does Maternal Instruction Prevent Kernicterus in Nigeria?
A study testing maternal education in people with Kernicterus, run by Bilimetrix s.r.l..
Trial summary
This study examines (a) whether introduction of public, health provider, and maternal education about risks of jaundice will decrease the occurrence of ABE compared with baseline prevalence (before-after design) or (b) whether antenatal or postpartum instruction to mothers will decrease the incidence of ABE compared… Read more about this study
- Who is it for?
- Ages 30 minutes to 21 days
- Conditions the study is for
- Kernicterus
- What is being tested?
- maternal education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,765 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Nov 2015
- Phase
- Interventional
- 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 30 minutes to 21 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn infant receiving treatment for neonatal jaundice
Who cannot join
- Non-viable premature infants
- Severe congenital defects.
- Postnatal age greater than 21 days
About this study
Official title: Effect of Education on Prevalence of Kernicterus in Five Regions in Nigeria
This study examines (a) whether introduction of public, health provider, and maternal education about risks of jaundice will decrease the occurrence of ABE compared with baseline prevalence (before-after design) or (b) whether antenatal or postpartum instruction to mothers will decrease the incidence of ABE compared with those who did not received instruction (concurrent opportunistic controls in phase 2).
Read the detailed description
This 2 phase study first determines the prevalence of acute bilirubin encephalopathy (ABE) among newborns admitted for treatment of jaundice at 5 regional centers in Nigeria and identifies social/behavioral/medical factors associated with ABE. Information gained in phase 1 identified high risk sub-populations and guided selection of instructional materials for phase 2. Core data sheets submitted monthly by participating centers included clinical data, demographic information, number of antenatal clinic visits, birth place (hospital, clinic, home) and attendant, distance from care centers and reasons for delay, if any, in seeking care. Receipt of jaundice instruction by mothers is self-reported. Statistical analysis includes Chi square and logistic regression analysis of risk factors. Sample size: 1,000 subjects in each phase are required to demonstrate a 20% decrease in disease prevalence (baseline ABE incidence anticipated to be 15% of jaundiced babies) at 95% confidence level.
- Conditions
- Kernicterus
- Being tested
- maternal education
- Medical subject headings
- Kernicterus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maternal educationBehavioural
Antenatal and/or postpartum Instruction on risks of neonatal jaundice, dangerous practices, technique to evaluate jaundice, early signs of ABE, when to seek care.
| Study group | Role | What they receive |
|---|---|---|
| maternal education | Active comparator | Phase IIa: Pregnant women attending antenatal clinics or postpartum in clinics or hospital who receive programmed maternal education about risks and care of newborn jaundice. Receives: Behavioral: maternal education |
| Historic control | No intervention | Phase I: (before-after design) Baseline prevalence of acute bilirubin encephalopathy before maternal education instituted. |
| No intervention | No intervention | Phase IIb: Opportunistic controls - infants of mothers who failed to receive education about risks and care of newborn jaundice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute bilirubin encephalopathy
Clinical signs of bilirubin toxicity described by unique neurological features in the presence of hyperbilirubinemia: reported as yes, no, or suspect (mild signs)
Measured: at time of admission or discharge (1-21 days of life)
Secondary outcomes (1)
Death from acute bilirubin encephalopathy or combined ABE/sepsis
Clinical signs of severe bilirubin toxicity with or without clinical signs of sepsis
Measured: 1-21 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startJan 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for KernicterusStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,765 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bilimetrix s.r.l.
- Sponsor type
- University, hospital or other
- Collaborators
- Jos University Teaching Hospital, Bayern University Teaching Hospital, Ahmadu Bello University Teaching Hospital, Massey Street Children's Hospital, Federal Medical Center Asaba, University of Minnesota
- Responsible party
- Principal investigator, Richard Patridge Wennberg, Bilimetrix s.r.l.
- Investigators
- Stephen Oguche, MBBS, Study director, Jos University Teaching HospitalAbieyuwa Emokpae, MBBS, Study director, Massey Street Pediatric Hospital, LagosZubaida Farouk, MBBS, Study director, Aminu Kano Teaching HospitalAngela Okolo, MBBS, Study director, Federal Medical Center AsabaIsa Abdulkadir, MBBS, Study director, Ahmadu Bello University Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713464
- Sponsor's protocol ID
- SKIN1
- Status last verified
- Mar 2016
- First submitted
- 12 Mar 2016
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Johnson L, Bhutani VK, Karp K, Sivieri EM, Shapiro SM. Clinical report from the pilot USA Kernicterus Registry (1992 to 2004). J Perinatol. 2009 Feb;29 Suppl 1:S25-45. doi: 10.1038/jp.2008.211.
PubMed 19177057Shapiro SM. Chronic bilirubin encephalopathy: diagnosis and outcome. Semin Fetal Neonatal Med. 2010 Jun;15(3):157-63. doi: 10.1016/j.siny.2009.12.004. Epub 2010 Jan 29.
PubMed 20116355
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Education on Prevalence of Kernicterus in Five Regions in Nigeria
- ClinicalTrials.gov ID
- NCT02713464
- Acronym / sponsor ID
- SKIN1
- Conditions
- Kernicterus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,765 participants (actual)
- Lead sponsor
- Bilimetrix s.r.l.University, hospital or other
- Collaborators
- Jos University Teaching Hospital, Bayern University Teaching Hospital, Ahmadu Bello University Teaching Hospital, Massey Street Children's Hospital, Federal Medical Center Asaba, University of Minnesota
- Study start
- Jan 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Mar 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.
This study examines (a) whether introduction of public, health provider, and maternal education about risks of jaundice will decrease the occurrence of ABE compared with baseline prevalence (before-after design) or (b) whether antenatal or postpartum instruction to mothers will decrease the incidence of ABE compared with those who did not received instruction (concurrent opportunistic controls in phase 2).
Detailed description
This 2 phase study first determines the prevalence of acute bilirubin encephalopathy (ABE) among newborns admitted for treatment of jaundice at 5 regional centers in Nigeria and identifies social/behavioral/medical factors associated with ABE. Information gained in phase 1 identified high risk sub-populations and guided selection of instructional materials for phase 2. Core data sheets submitted monthly by participating centers included clinical data, demographic information, number of antenatal clinic visits, birth place (hospital, clinic, home) and attendant, distance from care centers and reasons for delay, if any, in seeking care. Receipt of jaundice instruction by mothers is self-reported. Statistical analysis includes Chi square and logistic regression analysis of risk factors. Sample size: 1,000 subjects in each phase are required to demonstrate a 20% decrease in disease prevalence (baseline ABE incidence anticipated to be 15% of jaundiced babies) at 95% confidence level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| maternal education | Active comparator | Behavioral: maternal educationPhase IIa: Pregnant women attending antenatal clinics or postpartum in clinics or hospital who receive programmed maternal education about risks and care of newborn jaundice. |
| Historic control | No intervention | –Phase I: (before-after design) Baseline prevalence of acute bilirubin encephalopathy before maternal education instituted. |
| No intervention | No intervention | –Phase IIb: Opportunistic controls - infants of mothers who failed to receive education about risks and care of newborn jaundice. |
Who may qualify
- Ages
- 30 minutes to 21 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Newborn infant receiving treatment for neonatal jaundice
Key exclusion criteria (3 listed)
- Non-viable premature infants
- Severe congenital defects.
- Postnatal age greater than 21 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maternal educationAntenatal and/or postpartum Instruction on risks of neonatal jaundice, dangerous practices, technique to evaluate jaundice, early signs of ABE, when to seek care. | Behavioural | maternal education |
Primary outcome
Acute bilirubin encephalopathy
Time frame: at time of admission or discharge (1-21 days of life)
Clinical signs of bilirubin toxicity described by unique neurological features in the presence of hyperbilirubinemia: reported as yes, no, or suspect (mild signs)
1 secondary outcome
Death from acute bilirubin encephalopathy or combined ABE/sepsis
Time frame: 1-21 days of life
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 18 Mar 2016.
- Results publication: PubMed 19177057Johnson L, Bhutani VK, Karp K, Sivieri EM, Shapiro SM. Clinical report from the pilot USA Kernicterus Registry (1992 to 2004). J Perinatol. 2009 Feb;29 Suppl 1:S25-45. doi: 10.1038/jp.2008.211.
- Results publication: PubMed 20116355Shapiro SM. Chronic bilirubin encephalopathy: diagnosis and outcome. Semin Fetal Neonatal Med. 2010 Jun;15(3):157-63. doi: 10.1016/j.siny.2009.12.004. Epub 2010 Jan 29.
- Individual participant dataSharing planned: Undecided
Related trials for Kernicterus
Not yet recruitingObservational study
Reliability of Transcutaneous Bilirubin Measurement According to the Skin Colour of Newborns
Neonatal Jaundice
Active, not recruitingPhase 2
Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration
Bilirubin Encephalopathy
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.
Stephen Oguche, MBBS study director
Jos University Teaching Hospital
Abieyuwa Emokpae, MBBS study director
Massey Street Pediatric Hospital, Lagos
Zubaida Farouk, MBBS study director
Aminu Kano Teaching Hospital
Questions about this trial
What is this clinical trial studying?
A study testing maternal education in people with Kernicterus, run by Bilimetrix s.r.l..
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 1 inclusion and 3 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 18 Mar 2016. 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?
Acute bilirubin encephalopathy (time frame: at time of admission or discharge (1-21 days of life)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02713464, which also lists 2 linked publications.
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 18 Mar 2016; AzTrials last refreshed its copy on 30 Oct 2026.