Ignite Creation Date:
2024-05-06 @ 8:20 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02713464
Status:
COMPLETED
Last Update Posted:
2016-03-18
First Post:
2016-03-12
Brief Title:
Does Maternal Instruction Prevent Kernicterus in Nigeria
Sponsor:
Bilimetrix srl
Organization:
Bilimetrix srl
Study Overview
Official Title:
Effect of Education on Prevalence of Kernicterus in Five Regions in Nigeria
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 socialbehavioralmedical 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 1000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None