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

NCT ID: NCT02156050

Last Updated: 2014-06-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-12-31

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.

Conditions

Neonatal Hyperbilirubinemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OBLOO device (MEDIPREMA)

two sessions of 4 hours Phototherapy treatment

Group Type: ACTIVE_COMPARATOR

two sessions of 4 hours Phototherapy treatment

Intervention Type: DEVICE

two sessions of 4 hours Phototherapy treatment

BBLOO Device (MEDIPREMA)

two sessions of 4 hours Phototherapy treatment

Group Type: EXPERIMENTAL

two sessions of 4 hours Phototherapy treatment

Intervention Type: DEVICE

two sessions of 4 hours Phototherapy treatment

Interventions

two sessions of 4 hours Phototherapy treatment

two sessions of 4 hours Phototherapy treatment

Intervention Type: DEVICE

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

• Minimum Eligible Age: 35 Weeks
• Maximum Eligible Age: 42 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Antoine Beclere

OTHER

Sponsor Role: collaborator

Bicetre Hospital

OTHER

Sponsor Role: collaborator

Association Pédiatrique des Groupes d'Acuueil et de Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

hopital Antoine Béclère

Clamart, , France

Site Status: RECRUITING

Bicetre Hospital

Le Kremlin-Bicêtre, , France

Site Status: RECRUITING

Countries

France

Central Contacts

emmanuelle letamendia, MD

Role: CONTACT

emmanuelle.letamendia@abc.aphp.fr

0145374641

claire boithias, MD

Role: CONTACT

claire.boithias@bct.aphp.fr

0145213205

Facility Contacts

emmanuelle letamendia

Role: primary

+33145374641

claire Boithias, MD

Role: primary

+33145213205

Other Identifiers

ICT-O2

Identifier Type: -

Identifier Source: org_study_id