Use of a New Phototherapy Device (BBloo®) for the Treatment of Hyperbilirubinemia in the Newborn Infant (ICT-O2)
Primary Purpose
Neonatal Hyperbilirubinemia
Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
two sessions of 4 hours Phototherapy treatment
Sponsored by
About this trial
This is an interventional treatment trial for Neonatal Hyperbilirubinemia
Eligibility 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
Sites / Locations
- hopital Antoine BéclèreRecruiting
- Bicetre HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
OBLOO device (MEDIPREMA)
BBLOO Device (MEDIPREMA)
Arm Description
two sessions of 4 hours Phototherapy treatment
two sessions of 4 hours Phototherapy treatment
Outcomes
Primary Outcome Measures
EDIN Scale
EDIN scale will be measured 3 times during phototherapy treatment (base line, at 1 hour and at 4 Hour)
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT02156050
First Posted
May 16, 2014
Last Updated
June 3, 2014
Sponsor
Association Pédiatrique des Groupes d'Acuueil et de Recherche
Collaborators
Hopital Antoine Beclere, Bicetre Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02156050
Brief Title
Use of a New Phototherapy Device (BBloo®) for the Treatment of Hyperbilirubinemia in the Newborn Infant
Acronym
ICT-O2
Official Title
Utilisation du Dispositif BBloo® Pour le Traitement de l'ictère néonatal : Satisfaction Des Parents et Des Personnels Soignants
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association Pédiatrique des Groupes d'Acuueil et de Recherche
Collaborators
Hopital Antoine Beclere, Bicetre Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Hyperbilirubinemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OBLOO device (MEDIPREMA)
Arm Type
Active Comparator
Arm Description
two sessions of 4 hours Phototherapy treatment
Arm Title
BBLOO Device (MEDIPREMA)
Arm Type
Experimental
Arm Description
two sessions of 4 hours Phototherapy treatment
Intervention Type
Device
Intervention Name(s)
two sessions of 4 hours Phototherapy treatment
Intervention Description
two sessions of 4 hours Phototherapy treatment
Primary Outcome Measure Information:
Title
EDIN Scale
Description
EDIN scale will be measured 3 times during phototherapy treatment (base line, at 1 hour and at 4 Hour)
Time Frame
base line, 60minutes, 240minutes
Secondary Outcome Measure Information:
Title
Evaluation of Blood Bilirubin level
Description
blood bilirubin concentration will be measured 3 times during phototherapy treatment (base line, at 12 hour and at 24 Hour)
Time Frame
base line, at 12 hour and at 24 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
emmanuelle letamendia, MD
Phone
0145374641
Email
emmanuelle.letamendia@abc.aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
claire boithias, MD
Phone
0145213205
Email
claire.boithias@bct.aphp.fr
Facility Information:
Facility Name
hopital Antoine Béclère
City
Clamart
ZIP/Postal Code
92140
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
emmanuelle letamendia
Phone
+33145374641
First Name & Middle Initial & Last Name & Degree
emmanuelle letamendia, MD
Facility Name
Bicetre Hospital
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94275
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
claire Boithias, MD
Phone
+33145213205
12. IPD Sharing Statement
Learn more about this trial
Use of a New Phototherapy Device (BBloo®) for the Treatment of Hyperbilirubinemia in the Newborn Infant
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