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

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ClinicalTrials.gov Identifier: NCT02156050
Recruitment Status : Unknown
Verified June 2014 by Association Pédiatrique des Groupes d'Acuueil et de Recherche.
Recruitment status was:  Recruiting
First Posted : June 5, 2014
Last Update Posted : June 5, 2014
Sponsor:
Collaborators:
Hopital Antoine Beclere
Bicetre Hospital
Information provided by (Responsible Party):
Association Pédiatrique des Groupes d'Acuueil et de Recherche

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Neonatal Hyperbilirubinemia Device: two sessions of 4 hours Phototherapy treatment Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Utilisation du Dispositif BBloo® Pour le Traitement de l'ictère néonatal : Satisfaction Des Parents et Des Personnels Soignants
Study Start Date : December 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice

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




Primary Outcome Measures :
  1. EDIN Scale [ Time Frame: base line, 60minutes, 240minutes ]
    EDIN scale will be measured 3 times during phototherapy treatment (base line, at 1 hour and at 4 Hour)


Secondary Outcome Measures :
  1. Evaluation of Blood Bilirubin level [ Time Frame: base line, at 12 hour and at 24 hour ]
    blood bilirubin concentration will be measured 3 times during phototherapy treatment (base line, at 12 hour and at 24 Hour)



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Ages Eligible for Study:   35 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02156050


Contacts
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Contact: emmanuelle letamendia, MD 0145374641 emmanuelle.letamendia@abc.aphp.fr
Contact: claire boithias, MD 0145213205 claire.boithias@bct.aphp.fr

Locations
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France
hopital Antoine Béclère Recruiting
Clamart, France, 92140
Contact: emmanuelle letamendia    +33145374641      
Principal Investigator: emmanuelle letamendia, MD         
Bicetre Hospital Recruiting
Le Kremlin-Bicêtre, France, 94275
Contact: claire Boithias, MD    +33145213205      
Sponsors and Collaborators
Association Pédiatrique des Groupes d'Acuueil et de Recherche
Hopital Antoine Beclere
Bicetre Hospital

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Responsible Party: Association Pédiatrique des Groupes d'Acuueil et de Recherche
ClinicalTrials.gov Identifier: NCT02156050     History of Changes
Other Study ID Numbers: ICT-O2
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: June 5, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
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Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Pathologic Processes
Infant, Newborn, Diseases