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

Centre Hospitalier Universitaire, Amiens

Status: Completed

Conditions: Jaundice, Neonatal; Preterm Infant; Phototherapy

Treatments: Other: bilirubin serum level determination; Other: Phototherapy

Study type: Observational

Funder types: Other

Identifiers

NCT03942757

PI2018_843_0021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: Under 1 day old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

observation before educational program

Description:

100 preterm infant medical records will be studied in a first part of this observational study

Treatment:

Other: Phototherapy

Other: bilirubin serum level determination

Observation after educational program

Description:

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.

Treatment:

Other: Phototherapy

Other: bilirubin serum level determination