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| Name | Class |
|---|---|
| Jos University Teaching Hospital | OTHER |
| Bayern University Teaching Hospital | UNKNOWN |
| Ahmadu Bello University Teaching Hospital | OTHER |
| Massey Street Children's Hospital |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maternal education | Behavioral | Antenatal and/or postpartum Instruction on risks of neonatal jaundice, dangerous practices, technique to evaluate jaundice, early signs of ABE, when to seek care. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | at time of admission or discharge (1-21 days of life) |
| Measure | Description | Time Frame |
|---|---|---|
| Death from acute bilirubin encephalopathy or combined ABE/sepsis | Clinical signs of severe bilirubin toxicity with or without clinical signs of sepsis | 1-21 days of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Oguche, MBBS | Jos University Teaching Hospital | Study Director |
| Abieyuwa Emokpae, MBBS | Massey Street Pediatric Hospital, Lagos | Study Director |
| Zubaida Farouk, MBBS | Aminu Kano Teaching Hospital | Study Director |
| Angela Okolo, MBBS | Federal Medical Center Asaba | Study Director |
| Isa Abdulkadir, MBBS | Ahmadu Bello University Teaching Hospital | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19177057 | Result | 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. | |
| 20116355 | Result | Shapiro 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. |
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| ID | Term |
|---|---|
| D007647 | Kernicterus |
| ID | Term |
|---|---|
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| OTHER |
| Federal Medical Center Asaba | UNKNOWN |
| University of Minnesota | OTHER |
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| D004899 | Erythroblastosis, Fetal |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007154 | Immune System Diseases |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |