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BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice

NCT04365998 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-23

No results posted yet for this study

Summary

About 50% of full-term newborns and 80% of premature infants develop jaundice which is due to hyperbilirubinemia. In the majority of cases, jaundice disappears naturally without treatment within three weeks of birth, but the bilirubin level may remain too high, which can lead to a serious neurological disease: kernicterus. To avoid this, a therapeutic management must be instituted, and in some cases, one or more phototherapy sessions (PT) may be prescribed.

The aim of this trial is to evaluate the safety and level of satisfaction of parents and healthcare team with one innovative device for phototherapy BUBOLight® included two removable strips of luminous textile incorporating optical fibers.

10 newborns requiring phototherapy, will be illuminated during four hours in one session of PT Bilirubin levels is taken at the start of phototherapy H0 and Controls are made at H+6 hours.

Conditions

  • Neonatal Jaundice

Interventions

DEVICE

BUBOLight® Device

1 session of phototherapy with BUBOLight® device during 4 hours.

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Thameur Rakza, MD · University Hospital, Lille

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-08
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04365998 on ClinicalTrials.gov