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BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator (BLUE)

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ClinicalTrials.gov Identifier: NCT03942757
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:
Phototherapy is routinely used in neonatal intensive care units for the treatment of jaundice. Guidelines focus mainly on bilirubin serum levels to start the phototherapy. Only few data are available about clinical management of phototherapy devices and subsequently the impact on bilirubin serum decrease. Especially there are no strong recommendations about phototherapy duration, irradiance measurements, incubator temperature and humidity settings. Various factors can influence irradiance and thus the preterm infant bilirubin serum decrease. This study aims at evaluating the impact of an educational program on the use and efficacy of phototherapy in a neonatal intensive care unit.

Condition or disease Intervention/treatment
Preterm Infant Jaundice, Neonatal Phototherapy Other: bilirubin serum level determination Other: Phototherapy

Detailed Description:

Only few data are available about clinical management of phototherapy devices for the treatment of jaundice in the preterm infant.

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Group/Cohort Intervention/treatment
observation before educational program
100 preterm infant medical records will be studied in a first part of this observational study
Other: bilirubin serum level determination
bilirubin serum level before and after phototherapy treatment will be measured

Other: 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.
Other: bilirubin serum level determination
bilirubin serum level before and after phototherapy treatment will be measured

Other: 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.




Primary Outcome Measures :
  1. Change in bilirubin serum level (μmol/L/h) [ Time Frame: before and 24 hours after start of phototherapy treatment ]
    Change in bilirubin serum level (μmol/L/h) = (end bilirubin (μmol/L) - start bilirubin (μmol/L)) / delay between the 2 measurements (h)


Biospecimen Retention:   Samples Without DNA
serum


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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prospective, monocentric, observational study. All the preterm infant with a jaundice requiring a treatment with phototherapy could been screened for eligibility criteria
Criteria

Inclusion Criteria:

  • preterm infant less than 35 weeks gestation
  • 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 more than 35 weeks of gestation
  • preterm infant with hemolytic disease
  • preterm infant with Jaundice related to a cholestasis
  • Jaundice requiring exchange transfusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942757


Contacts
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Contact: Pierre Tourneux, Pr (33)322087604 tourneux.pierre@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80480
Contact: Pierre Tourneux, Pr    (33)322087604    tourneux.pierre@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03942757     History of Changes
Other Study ID Numbers: PI2018_843_0021
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire, Amiens:
preterm infant
jaundice
bilirubin
phototherapy
educational program

Additional relevant MeSH terms:
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Bilirubin
Premature Birth
Jaundice
Jaundice, Neonatal
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs