BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator

Preterm Infant Clinical Trial

— BLUE  

Official title:

BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03942757
• Other study ID #: PI2018_843_0021
• Status: Completed
• Start date: May 2, 2019
• Est. completion date: March 19, 2020

Study information

• Verified date: March 2020
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 19, 2020
• Est. primary completion date: March 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Day

Eligibility

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

Related Conditions & MeSH terms

• Jaundice
• Jaundice, Neonatal
• Phototherapy
• Premature Birth
• Preterm Infant

Intervention

Other:
• bilirubin serum level determination
bilirubin serum level before and after phototherapy treatment will be measured
• 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.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bilirubin serum level (µmol/L/h)	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