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

Neonatal Hyperbilirubinemia Clinical Trial

— ICT-O2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02156050
• Other study ID #: ICT-O2
• Status: Recruiting
• Phase: Phase 4
• First received: May 16, 2014
• Last updated: June 3, 2014
• Start date: December 2013
• Est. completion date: December 2015

Study information

• Verified date: June 2014
• Source: Association Pédiatrique des Groupes d'Acuueil et de Recherche
• Contact: emmanuelle letamendia, MD
• Phone: 0145374641
• Email: emmanuelle.letamendia[@]abc.aphp.fr
• Is FDA regulated: No
• Health authority: France : Agence Nationale de sécurité du médicament et des produits de Santé (ANSM)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Weeks to 42 Weeks

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Neonatal Hyperbilirubinemia

Intervention

Device:
• two sessions of 4 hours Phototherapy treatment
two sessions of 4 hours Phototherapy treatment

Locations

Country	Name	City	State
France	hopital Antoine Béclère	Clamart
France	Bicetre Hospital	Le Kremlin-Bicêtre

Sponsors (3)

Lead Sponsor	Collaborator
Association Pédiatrique des Groupes d'Acuueil et de Recherche	Bicetre Hospital, Hopital Antoine Beclere

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No