BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator

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.

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Key information

Conditions

Preterm Infant Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Jaundice Jaundice, Neonatal Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Phototherapy Pregnancy Complications Premature Birth Signs and Symptoms Skin Manifestations Urogenital Diseases

Age range

Up to 1 day

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens

Amiens, 80480, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bilirubin serum level determination

Other

bilirubin serum level before and after phototherapy treatment will be measured

phototherapy

Other

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 outcomes

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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: BLUE

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: May 8, 2019
Registry last updated: Mar 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed