Use of a New Phototherapy Device (BBloo®) for the Treatment of Hyperbilirubinemia in the Newborn Infant (ICT-O2)

Utilisation du Dispositif BBloo® Pour le Traitement de l'ictère néonatal : Satisfaction Des Parents et Des Personnels Soignants

Jaundice occurs in most newborn infants. Most jaundice is benign, but because of the potential toxicity of bilirubin, newborn infants must be monitored to identify those who might develop severe hyperbilirubinemia an, in rare cases, acute bilirubin encephalopathy or kernicterus. Jaundice is a commonly observed, usually harmless condition in newborn infants during the first week after birth. However, in some babies the amount of bilirubin pigment can increase to dangerous levels and require treatment. Treatment of jaundice in newborn infants is done by placing them under phototherapy, a process of exposing their skin to light of a specific wavelength band. Fluorescent tubes or halogen lamps have been used as light sources for phototherapy for many years. A light-emitting diode (LED) is a newer type of light source which is power efficient, has a longer life and is portable with low heat production. Several technologies and devices are developed around this LED and specially a compact system.

The purpose of this study is to evaluate efficacity of LED phototherapy by comparing with conventional phototherapy (non-LED) and satisfaction of the parents and the professional staff about comfort of this new technology. The newborn infant is placed in a sleeper with the device B' bloo ® which maintains him in position (lap or dorsal) allowing to pass the blue light. This one is generated by the module LED and transmitted in the braid of optical fibers which takes place directly on the mattress of the cradle in which is placed the patient usually.

The device is endowed with an hour counter to schedule the time of treatment. The energy illumination varies between 3 and 4 mW / cm ² for an average 3,6 mW / cm ².

Study Overview

• Status: Unknown
• Conditions: Neonatal Hyperbilirubinemia
• Intervention / Treatment: Device: two sessions of 4 hours Phototherapy treatment

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Clamart, France, 92140
    • Recruiting
    • Hôpital Antoine Béclère
    • Contact: emmanuelle letamendia; Phone Number: +33145374641
    • Principal Investigator: emmanuelle letamendia, MD
  • Le Kremlin-Bicêtre, France, 94275
    • Recruiting
    • Bicetre Hospital
    • Contact: claire Boithias, MD; Phone Number: +33145213205

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 9 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Newborn infants ≥ 38 gestation weeks without or with risk factors of severe icterus (G6PD or pyruvate-kinase deficiency, red blood cells membrane defects, hemoglobinopathies, cephalohematoma or significant bruising, decreased breastfeeding)
• newborn at 35 and 38 gestation weeks without risk factor of severe icterus (qs)
• hyperbilirubinemia to deal according to the curves of indication of phototherapy of the APP on 2004
• no opposition of parents

Exclusion Criteria:

• opposition of parents
• newborn infants less than 33 weeks
• newborn infants at 35 or more weeks of gestation with risk factors of severe icterus
• Jaundice in first 12 hours
• Hyperbilirubinemia > 340 µmol/L whatever is the age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: OBLOO device (MEDIPREMA); two sessions of 4 hours Phototherapy treatment	Device: two sessions of 4 hours Phototherapy treatment; two sessions of 4 hours Phototherapy treatment
EXPERIMENTAL: BBLOO Device (MEDIPREMA); two sessions of 4 hours Phototherapy treatment	Device: two sessions of 4 hours Phototherapy treatment; two sessions of 4 hours Phototherapy treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EDIN Scale	EDIN scale will be measured 3 times during phototherapy treatment (base line, at 1 hour and at 4 Hour)	base line, 60minutes, 240minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Blood Bilirubin level	blood bilirubin concentration will be measured 3 times during phototherapy treatment (base line, at 12 hour and at 24 Hour)	base line, at 12 hour and at 24 hour

Collaborators and Investigators

• Sponsor: Association Pédiatrique des Groupes d'Acuueil et de Recherche
• Collaborators: Bicetre Hospital; Hopital Antoine Beclere

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ANTICIPATED): December 1, 2015
• Study Completion (ANTICIPATED): December 1, 2015

Study Registration Dates

• First Submitted: May 16, 2014
• First Submitted That Met QC Criteria: June 3, 2014
• First Posted (ESTIMATE): June 5, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): June 5, 2014
• Last Update Submitted That Met QC Criteria: June 3, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal
• Other Study ID Numbers: ICT-O2