BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator
NCT ID: NCT03942757
Last Updated: 2020-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2019-05-02
2020-03-19
Brief Summary
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Detailed Description
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This study is a prospective, monocentric, observational study. Preterm infant \< 35 weeks of gestation with a jaundice requiring phototherapy according to NICE guidelines can be included for the duration of the phototherapy treatment.
The decrease in bilirubin serum level before and after phototherapy treatment will be measured.
This decrease in bilirubin serum level will be assessed for two consecutive periods before and after an educational program on jaundice management of the preterm infant.
The investigators aim at demonstrating that an educational program could improve phototherapy management and result in a higher decrease in bilirubin serum during treatment of the preterm infant with jaundice.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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observation before educational program
100 preterm infant medical records will be studied in a first part of this observational study
bilirubin serum level determination
bilirubin serum level before and after phototherapy treatment will be measured
Phototherapy
Preterm infant \< 35 weeks of gestation with a jaundice requiring phototherapy according to NICE guidelines can be included for the duration of the phototherapy treatment.
Observation after educational program
An educational program will be implemented in the unit after this first period. 100 preterm infant will be included in a second part of this observational study.
bilirubin serum level determination
bilirubin serum level before and after phototherapy treatment will be measured
Phototherapy
Preterm infant \< 35 weeks of gestation with a jaundice requiring phototherapy according to NICE guidelines can be included for the duration of the phototherapy treatment.
Interventions
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bilirubin serum level determination
bilirubin serum level before and after phototherapy treatment will be measured
Phototherapy
Preterm infant \< 35 weeks of gestation with a jaundice requiring phototherapy according to NICE guidelines can be included for the duration of the phototherapy treatment.
Eligibility Criteria
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Inclusion Criteria
* preterm infant hospitalized in the neonatal intensive care unit of CHU Amiens-Picardie
* preterm infant placed in an incubator
* preterm infant with a jaundice requiring treatment according to NICE guidelines
* preterm infant with a no hemolytic disease
* preterm infant with informed written consent from the parents
Exclusion Criteria
* preterm infant with hemolytic disease
* preterm infant with Jaundice related to a cholestasis
* Jaundice requiring exchange transfusion
1 Day
ALL
No
Sponsors
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Centre Hospitalier Universitaire, Amiens
OTHER
Responsible Party
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Locations
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CHU Amiens
Amiens, , France
Countries
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Other Identifiers
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PI2018_843_0021
Identifier Type: -
Identifier Source: org_study_id
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