Clinical trial NCT03942757: BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator
Official title: BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Infant
Jaundice, Neonatal
Phototherapy
Keywords: preterm infant
jaundice
bilirubin
phototherapy
educational program
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 200
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in bilirubin serum level (μmol/L/h)
timeFrame: before and 24 hours after start of phototherapy treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References: