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出境医 / 临床实验 / BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator (BLUE)
BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator (BLUE)
Study Description
Brief 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. 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Preterm Infant Jaundice, Neonatal Phototherapy | Other: bilirubin serum level determination Other: Phototherapy |
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
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 200 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 1 Day |
| Official Title: | BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator |
| Actual Study Start Date : | May 2, 2019 |
| Actual Primary Completion Date : | March 19, 2020 |
| Actual Study Completion Date : | March 19, 2020 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
observation before educational program
100 preterm infant medical records will be studied in a first part of this observational study
|
Other: bilirubin serum level determination
bilirubin serum level before and after phototherapy treatment will be measured
Other: Phototherapy 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.
|
|
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.
|
Other: bilirubin serum level determination
bilirubin serum level before and after phototherapy treatment will be measured
Other: Phototherapy 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.
|
Outcome Measures
Primary Outcome Measures :
- 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)
Biospecimen Retention: Samples Without DNA
serum
Eligibility Criteria
| Ages Eligible for Study: | up to 1 Day (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Prospective, monocentric, observational study. All the preterm infant with a jaundice requiring a treatment with phototherapy could been screened for eligibility criteria
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Locations
| France | |
| CHU Amiens | |
| Amiens, France, 80480 | |
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 2, 2019 | ||||
| First Posted Date | May 8, 2019 | ||||
| Last Update Posted Date | March 23, 2020 | ||||
| Actual Study Start Date | May 2, 2019 | ||||
| Actual Primary Completion Date | March 19, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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)
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator | ||||
| Official Title | BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator | ||||
| Brief 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. 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 Type | Observational [Patient Registry] | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
||||
| Target Follow-Up Duration | 1 Day | ||||
| Biospecimen | Retention: Samples Without DNA Description:
serum
|
||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Prospective, monocentric, observational study. All the preterm infant with a jaundice requiring a treatment with phototherapy could been screened for eligibility criteria | ||||
| Condition |
|
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| Intervention |
|
||||
| Study Groups/Cohorts |
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
200 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Actual Study Completion Date | March 19, 2020 | ||||
| Actual Primary Completion Date | March 19, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | up to 1 Day (Child) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03942757 | ||||
| Other Study ID Numbers | PI2018_843_0021 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement |
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| Responsible Party | Centre Hospitalier Universitaire, Amiens | ||||
| Study Sponsor | Centre Hospitalier Universitaire, Amiens | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Centre Hospitalier Universitaire, Amiens | ||||
| Verification Date | March 2020 | ||||
