BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator

Completed

• Conditions: Jaundice, Neonatal; Preterm Infant; Phototherapy
• Interventions: Other: bilirubin serum level determination; Other: Phototherapy

• Registration Number: NCT03942757
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-05-02
• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-08
• Status Verified: 2020-03
• Primary Completion: 2020-03-19
• Study Completion: 2020-03-19
• Last Update Submitted: 2020-03-20
• Last Update Posted: 2020-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
observation before educational program	bilirubin serum level determination	100 preterm infant medical records will be studied in a first part of this observational study
observation before educational program	Phototherapy	100 preterm infant medical records will be studied in a first part of this observational study
Observation after educational program	Phototherapy	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.
Observation after educational program	bilirubin serum level determination	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.

Primary Outcome Measures

Name	Time	Method
Change in bilirubin serum level (μmol/L/h)	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)

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France