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

March 20, 2020 updated by: Centre Hospitalier Universitaire, Amiens
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80480
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 day (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
before and 24 hours after start of phototherapy treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 2, 2019

Primary Completion (ACTUAL)

March 19, 2020

Study Completion (ACTUAL)

March 19, 2020

Study Registration Dates

First Submitted

May 2, 2019

First Submitted That Met QC Criteria

May 7, 2019

First Posted (ACTUAL)

May 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2020

Last Update Submitted That Met QC Criteria

March 20, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2018_843_0021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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