PhototherapyLEDlightT1NCT03570775
Effectiveness, Safety and Perceptions With the Use of One LED Sleeping Bag Device in the Treatment of Neonatal Jaundice
A study testing Sleeping bag phototherapy and Conventional phototherapy in people with Phototherapy and Jaundice, Neonatal, run by Nathalie Charpak at 1 site in Colombia.
Trial summary
Objective: to evaluate the effectiveness, safety and level of satisfaction of parents and healthcare team with one innovative device for phototherapy to which a LED light mesh has been incorporated(a sleeping bag), comparing it with conventional hospital phototherapy. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Phototherapy, Jaundice, Neonatal
- What is being tested?
- Sleeping bag phototherapy and Conventional phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteColombia
- Study dates
- 1 Mar 2016to 5 Oct 2017
- Phase
- Interventional
- 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 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hyperbilirubinemia requiring phototherapy according to the guidelines of the American Academy of Pediatrics and management recommendations for preterm infants under 35 weeks, adopted by the newborn unit of San Ignacio University Hospital.
- Birth weight more than 2000 grams.
- Parents are required to sign informed consent where they agree to participate in the study
Who cannot join
- Diagnosis of pemphigus, scalded skin or burns that make phototherapy difficult.
- Patient who requires transfer for management in another institution by their health insurer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness, Safety and Perceptions With the Use of One Phototherapy LED Device: a Sleeping Bag for Hospital Treatment of Neonatal Jaundice
Objective: to evaluate the effectiveness, safety and level of satisfaction of parents and healthcare team with one innovative device for phototherapy to which a LED light mesh has been incorporated(a sleeping bag), comparing it with conventional hospital phototherapy. Methods: randomized controlled clinical trial with newborns more than 2000 g of birth weight hospitalized requiring phototherapy. The study protocol was evaluated and accepted by the San Ignacio Hospital and "Pontificia Universidad Javeriana" research committee. Informed consent was requested from parents and the authors declared no conflict of interest. Sample size and allocation: using the STATA 12 program, a sample size of 58 patients was calculated, 29 for each group, with significance level of 0.05, power of 80% and difference in bilirubin decreasing of at least 0,1 mg/dl/h with standard deviation of 0.14 mg/dl/h. A computer program randomized the allocation to the intervention and the concealment of the assignment was through sealed opaque envelopes. Bilirubin levels were taken at the start of phototherapy. Controls were at the beginning, every 8 hours and every 12 hours at the time of bilirubin stabilization in the case of hemolysis, or every 24 hours depending on risk factors. Axillary temperature was measured at the beginning of phototherapy, at 30 min, 60 min, 120 min and every 24 hours during intervention. Physical examination and daily water balance were performed. Parents and health personnel answered a survey on comfort and perceptions with the use of the devices at the end of phototherapy. Analysis: Comparison of means was made for the decrease of bilirubin levels and body temperatures and chi-square for incidence of side effects and results of the survey.
Read the detailed description
Background: Jaundice due to hyperbilirubinemia is the most common entity that requires medical management in neonates. About 50% of full-term newborns and 80% of premature infants develop jaundice. The effectiveness of phototherapy for neonatal jaundice depends on two factors: the spectrum of light emitted and the spectral irradiation of light. An ideal phototherapy device should have a broad light emission surface, in order to cover the maximum of the body surface in the horizontal plane, it should be durable, generate relatively little heat and provide a wavelength and light intensity (radiation) optimal (460-490nm and ≥ 30uw / cm2 / nm). The conventional phototherapy devices use fluorescent lamps that emit heat and require eye protectors, in addition to increasing water losses, which requires a permanent monitoring of vital functions and temperature. Its use imposes hospitalization and consequently mother-child separation, always traumatic. The most recent devices use light emitting diodes (LED light) as the light source. Objective: to evaluate the effectiveness, safety and level of satisfaction of parents and healthcare team with one innovative device for phototherapy to which a LED light mesh has been incorporated (a sleeping bag ), comparing it with conventional phototherapy for hospitalized patients. Methods: randomized controlled clinical trial with newborns more than 2000 g of birth weight that required phototherapy according to the guidelines of the American Academy of Pediatrics, admitted to the "Hospital Universitario San Ignacio Neonata Care Unit (NCU)" . The Protocol was evaluated and accepted by the Hospital and "Pontificia Universidad Javeriana" research committee. Informed consent was requested from parents and the authors declared no conflict of interest. Sample size and allocation: using the STATA 12 program, a sample size of 58 patients was calculated, 29 for each group, with significance level of 0.05, power of 80% and difference in bilirubin decreasing of at least 0,1 mg/dl/h with standard deviation of 0.14 mg/dl/h. A computer program randomized the allocation to the intervention and the concealment of the assignment was through sealed opaque envelopes. Seric bilirubin levels were taken at the start and at the end of phototherapy. Controls were at the beginning, every 8 hours and every 12 hours at the time of bilirubin stabilization in the case of hemolysis, or every 24 hours depending on risk factors. Axillary temperature was measured at the beginning and during phototherapy. Physical examination and daily water balance were performed. Parents and health personnel answered a survey on comfort and perceptions with the use of the devices at the end of the intervention. Analysis: Comparison of means was made for decrease of bilirubin levels and body temperatures and chi-square for incidence of side effects and results of the survey.
- Conditions
- Phototherapy, Jaundice, Neonatal
- Being tested
- Sleeping bag phototherapy, Conventional phototherapy
- Keywords
- hyperbilirubinemia, treatment, devices, newborn, phototherapy
- Medical subject headings
- Jaundice, Neonatal, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeping bag phototherapyDevice
Also called "Neomedlight" sleeping bag phototherapy device
This device has a LED light emitter that incorporates one fiber optic mesh and is protected by a vinyl cover and a disposable liner for patient comfort and hygiene. The phototherapy sleeping bag is conceived with the aim of increasing the surface of phototherapy by means of a double exposure: ventral and dorsal, which allows the insertion of two phototherapy devices of 20x30 centimeters. The ventral and dorsal caps incorporate mesh optical fibers that are connected to the light emitter, in which the phototherapy time can be programmed. The fiber optic meshes are protected by a vinyl cover and a disposable lining for patient comfort and hygiene.
Conventional phototherapyDevice
Also called LU-6T phototherapy
This is a phototherapy device with six fluorescent tubes, four white and two blue, with adjustment of inclination and height incorporated. The device has a minimum height of 106 cm and a maximum of 152 cm, a depth of 64 cm and a width of 72 cm. The manufacturer recommends not using the lamp at distances of less than 50 cm because, although the heat radiation is minimal, this can influence distances less than 50 cm when the child is also exposed to infrared thermal radiation, typical of the servo cribs It is recommended to control temperature and eye protection due to the risk of ophthalmic injury from light, since the intensity of the light is concentrated in a single point.
| Study group | Role | What they receive |
|---|---|---|
| "Neomedlight" Sleeping bag phototherapy | Experimental | Phototherapy device with LED light + fiber optic mesh Receives: Device: Sleeping bag phototherapy |
| Conventional phototherapy | Active comparator | LU-6T model: phototherapy device with six fluorescent tubes, four white and two blue, with adjustment of inclination and height incorporated. Receives: Device: Conventional phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilirubin reduction rate in mg/dl/h
Bilirubin lowering rate (initial seric bilirubin- final seric bilirubin/time of phototherapy)
Measured: through study completion, an average of 5 days
Secondary outcomes (9)
Patient temperature during phototherapy
Axillary temperatures at 30 min, 60 min, 120 min, diary and at the end of phototherapy
Measured: through study completion, an average of 5 days
Incidence of skin lesions related to phototherapy
rash, burns, etc... related to phototherapy
Measured: through study completion, an average of 5 days
Incidence of dehydration related to phototherapy
documented with water balance and weight
Measured: through study completion, an average of 5 days
Incidence of diarrhea related to phototherapy
documented diarrhea
Measured: through study completion, an average of 5 days
Incidence of other side effects related to phototherapy
other effects recorded in clinic history related to phototherapy
Measured: through study completion, an average of 5 days
Perceptions of parents with the use of devices (comfort, heat, humidity, ease of breastfeeding, proximity and possibility of contact with the baby)
Validated survey at the end of treatment with Likert Scale( range 1 to 7. 1= completely uncomfortable. 7= completely comfortable. 4=indifferent)
Measured: at study completion, an average of 5 days
Perceptions of the health team with the use of the devices (comfort, heat, humidity, ease of breastfeeding, proximity and possibility of contact with the baby)
Validated survey at the end of treatment with Likert Scale( range 1 to 7. 1= completely uncomfortable. 7= completely comfortable. 4=indifferent)
Measured: at study completion, an average of 5 days
Incidence of mortality
Mortality related to treatment
Measured: through study completion, an average of 5 days
Incidence of exchange transfusion
Incidence of patients who required exchange transfusion.
Measured: through study completion, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start1 Mar 2016
- Primary completion2 Oct 2017
- Study completion5 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhototherapyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial with newborns over 2000 grams of birth weight and diagnosis of indirect hyperbilirubinemia, requiring phototherapy. Patients were randomized to phototherapy with the LED sleeping bag or conventional phototherapy with blue light panels.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nathalie Charpak
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario San Ignacio, Pontificia Universidad Javeriana
- Responsible party
- Sponsor-investigator, Nathalie Charpak, Kangaroo Foundation
- Investigators
- Margarita Andrade, Dr., Study chair, Hospital Universitario San IgnacioNathalie Charpak, Dr., Study director, Kangaroo Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570775
- Sponsor's protocol ID
- 2015/186
- Acronym
- LEDlightT1
- Status last verified
- Jun 2018
- First submitted
- 4 Jun 2018
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness, Safety and Perceptions With the Use of One Phototherapy LED Device: a Sleeping Bag for Hospital Treatment of Neonatal Jaundice
- ClinicalTrials.gov ID
- NCT03570775
- Acronym / sponsor ID
- LEDlightT1 / 2015/186
- Conditions
- Phototherapy, Jaundice, Neonatal
- Keywords
- hyperbilirubinemia, treatment, devices, newborn, phototherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Nathalie CharpakUniversity, hospital or other
- Collaborators
- Hospital Universitario San Ignacio, Pontificia Universidad Javeriana
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 2 Oct 2017 (actual)
- Study completion
- 5 Oct 2017 (actual)
- First posted
- 27 Jun 2018 (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.
Objective: to evaluate the effectiveness, safety and level of satisfaction of parents and healthcare team with one innovative device for phototherapy to which a LED light mesh has been incorporated(a sleeping bag), comparing it with conventional hospital phototherapy. Methods: randomized controlled clinical trial with newborns more than 2000 g of birth weight hospitalized requiring phototherapy. The study protocol was evaluated and accepted by the San Ignacio Hospital and "Pontificia Universidad Javeriana" research committee. Informed consent was requested from parents and the authors declared no conflict of interest. Sample size and allocation: using the STATA 12 program, a sample size of 58 patients was calculated, 29 for each group, with significance level of 0.05, power of 80% and difference in bilirubin decreasing of at least 0,1 mg/dl/h with standard deviation of 0.14 mg/dl/h. A computer program randomized the allocation to the intervention and the concealment of the assignment was through sealed opaque envelopes. Bilirubin levels were taken at the start of phototherapy. Controls were at the beginning, every 8 hours and every 12 hours at the time of bilirubin stabilization in the case of hemolysis, or every 24 hours depending on risk factors. Axillary temperature was measured at the beginning of phototherapy, at 30 min, 60 min, 120 min and every 24 hours during intervention. Physical examination and daily water balance were performed. Parents and health personnel answered a survey on comfort and perceptions with the use of the devices at the end of phototherapy. Analysis: Comparison of means was made for the decrease of bilirubin levels and body temperatures and chi-square for incidence of side effects and results of the survey.
Detailed description
Background: Jaundice due to hyperbilirubinemia is the most common entity that requires medical management in neonates. About 50% of full-term newborns and 80% of premature infants develop jaundice. The effectiveness of phototherapy for neonatal jaundice depends on two factors: the spectrum of light emitted and the spectral irradiation of light. An ideal phototherapy device should have a broad light emission surface, in order to cover the maximum of the body surface in the horizontal plane, it should be durable, generate relatively little heat and provide a wavelength and light intensity (radiation) optimal (460-490nm and ≥ 30uw / cm2 / nm). The conventional phototherapy devices use fluorescent lamps that emit heat and require eye protectors, in addition to increasing water losses, which requires a permanent monitoring of vital functions and temperature. Its use imposes hospitalization and consequently mother-child separation, always traumatic. The most recent devices use light emitting diodes (LED light) as the light source. Objective: to evaluate the effectiveness, safety and level of satisfaction of parents and healthcare team with one innovative device for phototherapy to which a LED light mesh has been incorporated (a sleeping bag ), comparing it with conventional phototherapy for hospitalized patients. Methods: randomized controlled clinical trial with newborns more than 2000 g of birth weight that required phototherapy according to the guidelines of the American Academy of Pediatrics, admitted to the "Hospital Universitario San Ignacio Neonata Care Unit (NCU)" . The Protocol was evaluated and accepted by the Hospital and "Pontificia Universidad Javeriana" research committee. Informed consent was requested from parents and the authors declared no conflict of interest. Sample size and allocation: using the STATA 12 program, a sample size of 58 patients was calculated, 29 for each group, with significance level of 0.05, power of 80% and difference in bilirubin decreasing of at least 0,1 mg/dl/h with standard deviation of 0.14 mg/dl/h. A computer program randomized the allocation to the intervention and the concealment of the assignment was through sealed opaque envelopes. Seric bilirubin levels were taken at the start and at the end of phototherapy. Controls were at the beginning, every 8 hours and every 12 hours at the time of bilirubin stabilization in the case of hemolysis, or every 24 hours depending on risk factors. Axillary temperature was measured at the beginning and during phototherapy. Physical examination and daily water balance were performed. Parents and health personnel answered a survey on comfort and perceptions with the use of the devices at the end of the intervention. Analysis: Comparison of means was made for decrease of bilirubin levels and body temperatures and chi-square for incidence of side effects and results of the survey.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial with newborns over 2000 grams of birth weight and diagnosis of indirect hyperbilirubinemia, requiring phototherapy. Patients were randomized to phototherapy with the LED sleeping bag or conventional phototherapy with blue light panels.
| Arm | Type | Receives |
|---|---|---|
| "Neomedlight" Sleeping bag phototherapy | Experimental | Device: Sleeping bag phototherapyPhototherapy device with LED light + fiber optic mesh |
| Conventional phototherapy | Active comparator | Device: Conventional phototherapyLU-6T model: phototherapy device with six fluorescent tubes, four white and two blue, with adjustment of inclination and height incorporated. |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Hyperbilirubinemia requiring phototherapy according to the guidelines of the American Academy of Pediatrics and management recommendations for preterm infants under 35 weeks, adopted by the newborn unit of San Ignacio University Hospital.
- Birth weight more than 2000 grams.
- Parents are required to sign informed consent where they agree to participate in the study
Key exclusion criteria (2 listed)
- Diagnosis of pemphigus, scalded skin or burns that make phototherapy difficult.
- Patient who requires transfer for management in another institution by their health insurer.
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 |
|---|---|---|
| Sleeping bag phototherapyAlso: "Neomedlight" sleeping bag phototherapy deviceThis device has a LED light emitter that incorporates one fiber optic mesh and is protected by a vinyl cover and a disposable liner for patient comfort and hygiene. The phototherapy sleeping bag is conceived with the aim of increasing the surface of phototherapy by means of a double exposure: ventral and dorsal, which allows the insertion of two phototherapy devices of 20x30 centimeters. The ventral and dorsal caps incorporate mesh optical fibers that are connected to the light emitter, in which the phototherapy time can be programmed. The fiber optic meshes are protected by a vinyl cover and a disposable lining for patient comfort and hygiene. | Device | "Neomedlight" Sleeping bag phototherapy |
| Conventional phototherapyAlso: LU-6T phototherapyThis is a phototherapy device with six fluorescent tubes, four white and two blue, with adjustment of inclination and height incorporated. The device has a minimum height of 106 cm and a maximum of 152 cm, a depth of 64 cm and a width of 72 cm. The manufacturer recommends not using the lamp at distances of less than 50 cm because, although the heat radiation is minimal, this can influence distances less than 50 cm when the child is also exposed to infrared thermal radiation, typical of the servo cribs It is recommended to control temperature and eye protection due to the risk of ophthalmic injury from light, since the intensity of the light is concentrated in a single point. | Device | Conventional phototherapy |
Primary outcome
Bilirubin reduction rate in mg/dl/h
Time frame: through study completion, an average of 5 days
Bilirubin lowering rate (initial seric bilirubin- final seric bilirubin/time of phototherapy)
9 secondary outcomes
Patient temperature during phototherapy
Time frame: through study completion, an average of 5 days
Incidence of skin lesions related to phototherapy
Time frame: through study completion, an average of 5 days
Incidence of dehydration related to phototherapy
Time frame: through study completion, an average of 5 days
Incidence of diarrhea related to phototherapy
Time frame: through study completion, an average of 5 days
Incidence of other side effects related to phototherapy
Time frame: through study completion, an average of 5 days
Perceptions of parents with the use of devices (comfort, heat, humidity, ease of breastfeeding, proximity and possibility of contact with the baby)
Time frame: at study completion, an average of 5 days
Perceptions of the health team with the use of the devices (comfort, heat, humidity, ease of breastfeeding, proximity and possibility of contact with the baby)
Time frame: at study completion, an average of 5 days
Incidence of mortality
Time frame: through study completion, an average of 5 days
Incidence of exchange transfusion
Time frame: through study completion, an average of 5 days
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 27 Jun 2018.
- 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.
Margarita Andrade, Dr. study chair
Hospital Universitario San Ignacio
Nathalie Charpak, Dr. study director
Kangaroo Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleeping bag phototherapy and Conventional phototherapy in people with Phototherapy and Jaundice, Neonatal, run by Nathalie Charpak at 1 site in Colombia.
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 3 inclusion and 2 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 27 Jun 2018. 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 Colombia. 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?
Bilirubin reduction rate in mg/dl/h (time frame: through study completion, an average of 5 days). 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 27 Jun 2018.