Preterm InfantBLUENCT03942757
BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator
An observational study of Preterm Infant and Jaundice, Neonatal, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Phototherapy is routinely used in neonatal intensive care units for the treatment of jaundice. Guidelines focus mainly on bilirubin serum levels to start the phototherapy. Only few data are available about clinical management of phototherapy devices and subsequently the impact on bilirubin serum decrease. Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Preterm Infant, Jaundice, Neonatal, Phototherapy
- What is being tested?
- bilirubin serum level determination and Phototherapy
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2019to 19 Mar 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 Up to 1 day
- All sexes
- No healthy volunteers
- Child
Study population: Prospective, monocentric, observational study. All the preterm infant with a jaundice requiring a treatment with phototherapy could been screened for eligibility criteria
Who may be able to join
- preterm infant less than 35 weeks gestation
- preterm infant hospitalized in the neonatal intensive care unit of CHU Amiens-Picardie
- preterm infant placed in an incubator
- preterm infant with a jaundice requiring treatment according to NICE guidelines
- preterm infant with a no hemolytic disease
- preterm infant with informed written consent from the parents
Who cannot join
- preterm infant more than 35 weeks of gestation
- preterm infant with hemolytic disease
- preterm infant with Jaundice related to a cholestasis
- Jaundice requiring exchange transfusion
Trial locations and contacts
1 site in 1 country.
About this study
Phototherapy is routinely used in neonatal intensive care units for the treatment of jaundice. Guidelines focus mainly on bilirubin serum levels to start the phototherapy. Only few data are available about clinical management of phototherapy devices and subsequently the impact on bilirubin serum decrease. Especially there are no strong recommendations about phototherapy duration, irradiance measurements, incubator temperature and humidity settings. Various factors can influence irradiance and thus the preterm infant bilirubin serum decrease. This study aims at evaluating the impact of an educational program on the use and efficacy of phototherapy in a neonatal intensive care unit.
Read the detailed description
Only few data are available about clinical management of phototherapy devices for the treatment of jaundice in the preterm infant.
This study is a prospective, monocentric, observational study. Preterm infant < 35 weeks of gestation with a jaundice requiring phototherapy according to NICE guidelines can be included for the duration of the phototherapy treatment.
The decrease in bilirubin serum level before and after phototherapy treatment will be measured.
This decrease in bilirubin serum level will be assessed for two consecutive periods before and after an educational program on jaundice management of the preterm infant.
The investigators aim at demonstrating that an educational program could improve phototherapy management and result in a higher decrease in bilirubin serum during treatment of the preterm infant with jaundice.
- Conditions
- Preterm Infant, Jaundice, Neonatal, Phototherapy
- Being tested
- bilirubin serum level determination, Phototherapy
- Keywords
- preterm infant, jaundice, bilirubin, phototherapy, educational program
- Medical subject headings
- Premature Birth, Jaundice, Neonatal, Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilirubin serum level determinationOther
bilirubin serum level before and after phototherapy treatment will be measured
PhototherapyOther
Preterm infant < 35 weeks of gestation with a jaundice requiring phototherapy according to NICE guidelines can be included for the duration of the phototherapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| observation before educational program | 100 preterm infant medical records will be studied in a first part of this observational study Receives: Other: bilirubin serum level determination; Other: Phototherapy | |
| Observation after educational program | An educational program will be implemented in the unit after this first period. 100 preterm infant will be included in a second part of this observational study. Receives: Other: bilirubin serum level determination; Other: Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bilirubin serum level (μmol/L/h)
Change in bilirubin serum level (μmol/L/h) = (end bilirubin (μmol/L) - start bilirubin (μmol/L)) / delay between the 2 measurements (h)
Measured: before and 24 hours after start of phototherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start2 May 2019
- Primary completion19 Mar 2020
- Study completion19 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942757
- Sponsor's protocol ID
- PI2018_843_0021
- Acronym
- BLUE
- Status last verified
- Mar 2020
- First submitted
- 2 May 2019
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator
- ClinicalTrials.gov ID
- NCT03942757
- Acronym / sponsor ID
- BLUE / PI2018_843_0021
- Conditions
- Preterm Infant, Jaundice, Neonatal, Phototherapy
- Keywords
- preterm infant, jaundice, bilirubin, phototherapy, educational program
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 2 May 2019 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 8 May 2019 (actual)
- 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.
Phototherapy is routinely used in neonatal intensive care units for the treatment of jaundice. Guidelines focus mainly on bilirubin serum levels to start the phototherapy. Only few data are available about clinical management of phototherapy devices and subsequently the impact on bilirubin serum decrease. Especially there are no strong recommendations about phototherapy duration, irradiance measurements, incubator temperature and humidity settings. Various factors can influence irradiance and thus the preterm infant bilirubin serum decrease. This study aims at evaluating the impact of an educational program on the use and efficacy of phototherapy in a neonatal intensive care unit.
Detailed description
Only few data are available about clinical management of phototherapy devices for the treatment of jaundice in the preterm infant.
This study is a prospective, monocentric, observational study. Preterm infant < 35 weeks of gestation with a jaundice requiring phototherapy according to NICE guidelines can be included for the duration of the phototherapy treatment.
The decrease in bilirubin serum level before and after phototherapy treatment will be measured.
This decrease in bilirubin serum level will be assessed for two consecutive periods before and after an educational program on jaundice management of the preterm infant.
The investigators aim at demonstrating that an educational program could improve phototherapy management and result in a higher decrease in bilirubin serum during treatment of the preterm infant with jaundice.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| observation before educational program | – | Other: bilirubin serum level determination, Other: Phototherapy100 preterm infant medical records will be studied in a first part of this observational study |
| Observation after educational program | – | Other: bilirubin serum level determination, Other: PhototherapyAn educational program will be implemented in the unit after this first period. 100 preterm infant will be included in a second part of this observational study. |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Prospective, monocentric, observational study. All the preterm infant with a jaundice requiring a treatment with phototherapy could been screened for eligibility criteria
Key inclusion criteria (6 listed)
- preterm infant less than 35 weeks gestation
- preterm infant hospitalized in the neonatal intensive care unit of CHU Amiens-Picardie
- preterm infant placed in an incubator
- preterm infant with a jaundice requiring treatment according to NICE guidelines
- preterm infant with a no hemolytic disease
Key exclusion criteria (4 listed)
- preterm infant more than 35 weeks of gestation
- preterm infant with hemolytic disease
- preterm infant with Jaundice related to a cholestasis
- Jaundice requiring exchange transfusion
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 |
|---|---|---|
| bilirubin serum level determinationbilirubin serum level before and after phototherapy treatment will be measured | Other | Observation after educational program, observation before educational program |
| PhototherapyPreterm infant < 35 weeks of gestation with a jaundice requiring phototherapy according to NICE guidelines can be included for the duration of the phototherapy treatment. | Other | Observation after educational program, observation before educational program |
Primary outcome
Change in bilirubin serum level (μmol/L/h)
Time frame: before and 24 hours after start of phototherapy treatment
Change in bilirubin serum level (μmol/L/h) = (end bilirubin (μmol/L) - start bilirubin (μmol/L)) / delay between the 2 measurements (h)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Infant and Jaundice, Neonatal, run by Centre Hospitalier Universitaire, Amiens at 1 site 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bilirubin serum level (μmol/L/h) (time frame: before and 24 hours after start of phototherapy treatment). 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 23 Mar 2020.