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

NCT02156050 | Unknown Phase 4

• 1 other identifier: ICT-O2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of Blood Bilirubin level

  base line, at 12 hour and at 24 hour

Study Arms (2)

OBLOO device (MEDIPREMA)

ACTIVE COMPARATOR

two sessions of 4 hours Phototherapy treatment

Device: two sessions of 4 hours Phototherapy treatment

BBLOO Device (MEDIPREMA)

EXPERIMENTAL

two sessions of 4 hours Phototherapy treatment

Device: two sessions of 4 hours Phototherapy treatment

Interventions

two sessions of 4 hours Phototherapy treatment DEVICE

two sessions of 4 hours Phototherapy treatment

BBLOO Device (MEDIPREMA); OBLOO device (MEDIPREMA)

Eligibility Criteria

• Age: 35 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Association Pédiatrique des Groupes d'Acuueil et de Recherche: lead
• Hopital Antoine Beclere: collaborator
• Bicetre Hospital: collaborator

Study Sites (2)

hopital Antoine Béclère

Clamart, 92140, France

RECRUITING

Bicetre Hospital

Le Kremlin-Bicêtre, 94275, France

RECRUITING

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

emmanuelle letamendia, MD

CONTACT

0145374641; emmanuelle.letamendia@abc.aphp.fr

claire boithias, MD

CONTACT

0145213205; claire.boithias@bct.aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: June 5, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 5, 2014

Record last verified: 2014-06

Locations

FR (2)