NCT02713464

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,765

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
Last Updated

March 18, 2016

Status Verified

March 1, 2016

Enrollment Period

1.8 years

First QC Date

March 12, 2016

Last Update Submit

March 17, 2016

Conditions

Kernicterus

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Death from acute bilirubin encephalopathy or combined ABE/sepsis

    1-21 days of life

Study Arms (3)

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.

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.

Interventions

maternal educationBEHAVIORAL

Antenatal and/or postpartum Instruction on risks of neonatal jaundice, dangerous practices, technique to evaluate jaundice, early signs of ABE, when to seek care.

maternal education

Eligibility Criteria

Age30 Minutes - 21 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Newborn infant receiving treatment for neonatal jaundice

You may not qualify if:

  • Non-viable premature infants
  • Severe congenital defects.
  • Postnatal age greater than 21 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 19177057RESULT

  • 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.

    PMID: 20116355RESULT

MeSH Terms

Conditions

Kernicterus

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Brain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesErythroblastosis, FetalHematologic DiseasesHemic and Lymphatic DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesImmune System DiseasesHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 12, 2016

First Posted

March 18, 2016

Study Start

January 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

March 18, 2016

Record last verified: 2016-03