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BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator

BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03942757
Acronym
BLUE
Enrollment
200
Registered
2019-05-08
Start date
2019-05-02
Completion date
2020-03-19
Last updated
2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jaundice, Neonatal, Phototherapy, Preterm Infant

Keywords

preterm infant, jaundice, bilirubin, phototherapy, educational program

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.

Interventions

OTHERbilirubin serum level determination

bilirubin serum level before and after phototherapy treatment will be measured

OTHERPhototherapy

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.

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in bilirubin serum level (μmol/L/h)before and 24 hours after start of phototherapy treatmentChange in bilirubin serum level (μmol/L/h) = (end bilirubin (μmol/L) - start bilirubin (μmol/L)) / delay between the 2 measurements (h)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026