Neonatal HyperbilirubinemiaPhase 4ICT-O2NCT02156050
Use of a New Phototherapy Device (BBloo®) for the Treatment of Hyperbilirubinemia in the Newborn Infant
A Phase 4 study testing two sessions of 4 hours Phototherapy treatment in people with Neonatal Hyperbilirubinemia, run by Association Pédiatrique des Groupes d'Acuueil et de Recherche at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 35 to 42 weeks
- Conditions the study is for
- Neonatal Hyperbilirubinemia
- What is being tested?
- two sessions of 4 hours Phototherapy treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2013to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
hopital Antoine Béclère
Clamart, 92140
emmanuelle letamendia, +33145374641
emmanuelle letamendia, MD
- Recruiting
Bicetre Hospital
Le Kremlin-Bicêtre, 94275
claire Boithias, MD, +33145213205
About this study
Official title: Utilisation du Dispositif BBloo® Pour le Traitement de l'ictère néonatal : Satisfaction Des Parents et Des Personnels Soignants
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
- Being tested
- two sessions of 4 hours Phototherapy treatment
- Medical subject headings
- Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two sessions of 4 hours Phototherapy treatmentDevice
two sessions of 4 hours Phototherapy treatment
| Study group | Role | What they receive |
|---|---|---|
| OBLOO device (MEDIPREMA) | Active comparator | two sessions of 4 hours Phototherapy treatment Receives: Device: two sessions of 4 hours Phototherapy treatment |
| BBLOO Device (MEDIPREMA) | Experimental | two sessions of 4 hours Phototherapy treatment Receives: Device: two sessions of 4 hours Phototherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
EDIN Scale
EDIN scale will be measured 3 times during phototherapy treatment (base line, at 1 hour and at 4 Hour)
Measured: base line, 60minutes, 240minutes
Secondary outcomes (1)
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)
Measured: base line, at 12 hour and at 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal HyperbilirubinemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Pédiatrique des Groupes d'Acuueil et de Recherche
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Antoine Beclere, Bicetre Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156050
- Sponsor's protocol ID
- ICT-O2
- Acronym
- ICT-O2
- Status last verified
- Jun 2014
- First submitted
- 16 May 2014
- Last updated
- 5 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilisation du Dispositif BBloo® Pour le Traitement de l'ictère néonatal : Satisfaction Des Parents et Des Personnels Soignants
- ClinicalTrials.gov ID
- NCT02156050
- Acronym / sponsor ID
- ICT-O2 / ICT-O2
- Conditions
- Neonatal Hyperbilirubinemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Association Pédiatrique des Groupes d'Acuueil et de RechercheUniversity, hospital or other
- Collaborators
- Hopital Antoine Beclere, Bicetre Hospital
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OBLOO device (MEDIPREMA) | Active comparator | Device: two sessions of 4 hours Phototherapy treatmenttwo sessions of 4 hours Phototherapy treatment |
| BBLOO Device (MEDIPREMA) | Experimental | Device: two sessions of 4 hours Phototherapy treatmenttwo sessions of 4 hours Phototherapy treatment |
Who may qualify
- Ages
- 35 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| two sessions of 4 hours Phototherapy treatmenttwo sessions of 4 hours Phototherapy treatment | Device | BBLOO Device (MEDIPREMA), OBLOO device (MEDIPREMA) |
Primary outcome
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)
1 secondary outcome
Evaluation of Blood Bilirubin level
Time frame: base line, at 12 hour and at 24 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing two sessions of 4 hours Phototherapy treatment in people with Neonatal Hyperbilirubinemia, run by Association Pédiatrique des Groupes d'Acuueil et de Recherche at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact emmanuelle letamendia, MD (0145374641, emmanuelle.letamendia@abc.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EDIN Scale (time frame: base line, 60minutes, 240minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2014.