Neonatal HyperbilirubinemiaPhase 2/3NCT06702241
Newborn Jaundice - An Investigation of Different Approaches to Light Therapy
A Phase 2/3 study testing Continuous Phototherapy with a irradiance of 40 µW/cm2/nm from the overhead light, Continuos Phototherapy with a irradiance of 55 µW/cm2/nm from the overhead light and Continuous Phototherapy with a irradiance of 70 µW/cm2/nm from the overhead light in people with Neonatal Hyperbilirubinemia, run by Regionshospital Nordjylland at 2 sites in Denmark.
Trial summary
Background Neonatal jaundice affects about 60% of full-term newborns in their first week. If untreated, it can lead to permanent brain damage. In Denmark, 2-5% of newborns require phototherapy, the standard treatment. The maximum beneficial irradiance limit for phototherapy remains unclear. Read more about this study
- Who is it for?
- Ages 1 day to 14 days
- Conditions the study is for
- Neonatal Hyperbilirubinemia
- What is being tested?
- Continuous Phototherapy with a irradiance of 40 µW/cm2/nm from the overhead light, Continuos Phototherapy with a irradiance of 55 µW/cm2/nm from the overhead light and Continuous Phototherapy with a irradiance of 70 µW/cm2/nm from the overhead light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 2 sitesDenmark
- Study dates
- 14 Jan 2025to 1 Nov 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 1 day to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hyperbilirubinemia with a total serum bilirubin level above the limit of necessary treatment according to the Danish Pediatric Society's guidelines
- Birth weight >1800g
- Gestational age >33+0
Who cannot join
- Hyperbilirubinemia within the first 24 hours of life
- Rapidly increasing serum levels of bilirubnemia indicating pathology or hemolysis
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Aalborg University Hospital, The Neonatal Department
Aalborg, 9000
Lars Bender, MD, consultant, +45 97663355, labe@rn.dk
- Recruiting
The North Denmark Regional Hospital, The Pediatric Department
Hjørring, 9800
Mette L Roed, MD, +45 97642932, mld@rn.dk
About this study
Official title: Neonatal Hyperbilirubinemia - Phototherapeutic Treatment Strategies
Background Neonatal jaundice affects about 60% of full-term newborns in their first week. If untreated, it can lead to permanent brain damage. In Denmark, 2-5% of newborns require phototherapy, the standard treatment. The maximum beneficial irradiance limit for phototherapy remains unclear. Furthermore, studies suggest that cycled phototherapy is as effective as continuous treatment.
This study aims to investigate the efficacy of elevating the irradiance of intensive phototherapy treatment regimens. This is to evaluate the dose-response relationship. Furthermore, the study aims to compare intermittent phototherapy to continuous phototherapy.
Read more
Methods:
In a clinical randomized multicenter trial 116 newborns with non-hemolytic hyperbilirubinemia, gestational age >33+0, weight >1800g and no other significant neonatal diagnose will be randomized. All infants will receive 12 hours double therapy with a biliblanket and overhead light providing an intensity of either 40-, 55- or 70 µW/cm2/nm. Three groups will be treated with continuous phototherapy while a fourth group will receive intermittent phototherapy of 1,5 hours cycled intervals with an intensity of 70 µW/cm2/nm.
Parental experiences during treatment will be examined through a survey post treatment.
The study has been approved by the Regional Research Ethics Committee.
Perspectives:
Understanding the dose-response relationship of phototherapy will give an insight in the most effective way of treating neonatal jaundice. Intermittent therapy, if proven non-inferior, could facilitate more intimacy in the parent-infant relationship as well as benefits in initiating breastfeeding
Read the detailed description
A randomized clinical study is planned to determine whether there is an upper limit to the efficacy of phototherapy irradiance and whether intermittent/cyclic treatment is as effective as continuous treatment. The study will be conducted at the Maternity Ward and the Department of Pediatrics and Adolescents at the North Denmark Regional Hospital, as well as the Neonatal Department at Aalborg University Hospital. Power calculations require the inclusion of 29 children in each of the four groups, totaling 116 children.
Inclusion criteria are newborns born at ≥33+0 weeks of gestation and a birth weight of ≥1800 g, with a blood bilirubin level above the treatment threshold as specified in the national guidelines. Newborns with rapidly rising bilirubin levels, indicating the need for more intensive treatment with light from multiple sides, exchange transfusion, or possibly immunoglobulin, are excluded from the study.
All children will be treated with double light-overhead light and a light blanket-for 12 hours. The included children will be randomized into one of four groups, each with a specific irradiance level for overhead phototherapy: 40, 55, and 70 µW/cm²/nm. The light blanket under the child will provide an irradiance of 30 µW/cm²/nm. The 70 µW/cm²/nm group will be divided into two subgroups: continuous and intermittent treatment. Thus, there will be four groups in total. Irradiance can be measured and practically adjusted by modifying the distance between the child and the light source. For intermittent treatment, a strategy of 1.5 hours of phototherapy followed by a 1.5-hour pause will be used, based on experiences from other studies and to accommodate the family's and child's feeding needs.
The primary outcome is the reduction in total serum bilirubin, measured from the start of treatment to after 12 hours. Secondary outcomes will include recording whether any children experience a rebound increase in bilirubin. This will be done by reviewing the medical records of the included children to determine if a new blood test for serum bilirubin has been performed, indicating a rebound.
The children will be closely monitored for signs of early bilirubin encephalopathy through medical examinations, weight control, and records of food intake (either breast milk or formula). Serum bilirubin will be measured before the start of treatment. After 12 hours of treatment, serum bilirubin, hemoglobin, and photoisomers will be measured. Serum bilirubin must be measured no more than three hours before the start of phototherapy.
Data analysis will examine:
Differences between the three groups with varying light intensities. Differences between the two groups with the same irradiance but differing treatment regimens (intermittent vs. continuous).
Parents of children meeting the inclusion criteria will be presented with the project verbally and in writing by department staff in a quiet, undisturbed setting. Parents will have time to consider the project while awaiting blood test results and preparing for phototherapy. If parents cannot agree or decide, the child will not participate in the project.
The project is registered with the Research Projects Registry of the North Denmark Region (ID: F2024-032). The project is approved by the Danish Scientific Ethical Committee for Region North Jutland, registration number N-20240019.
Perspectives The study aims to enable more effective and shorter treatment for the 2-5% of all newborns receiving phototherapy. This will allow for more time to establish breastfeeding and bonding between the child and parent.
- Conditions
- Neonatal Hyperbilirubinemia
- Being tested
- Continuous Phototherapy with a irradiance of 40 µW/cm2/nm from the overhead light, Continuos Phototherapy with a irradiance of 55 µW/cm2/nm from the overhead light, Continuous Phototherapy with a irradiance of 70 µW/cm2/nm from the overhead light, Cycled phototherapy with a irradiance of 70 µW/cm2/nm from the overhead light
- Keywords
- Cycled phototherapy, high irradiance phototherapy, Neonatal jaundice, Newborn jaundice, neonatal hyperbilirubinemia
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Phototherapy with a irradiance of 40 µW/cm2/nm from the overhead lightOther
The difference in irradiance between the groups will be measured with a radiometer specific to the device's wavelength.
Continuos Phototherapy with a irradiance of 55 µW/cm2/nm from the overhead lightOther
The difference in irradiance between the groups will be measured with a radiometer specific for the device's wavelenght
Continuous Phototherapy with a irradiance of 70 µW/cm2/nm from the overhead lightOther
The difference in irradiance between the groups will be measured with a radiometer specific for the device's wavelenght
Cycled phototherapy with a irradiance of 70 µW/cm2/nm from the overhead lightOther
The difference in irradiance between the groups will be measured with a radiometer specific for the device's wavelenght
| Study group | Role | What they receive |
|---|---|---|
| 12 hours continuous double phototherapy with irradiance of over head light of 40 µW/cm2/nm | Active comparator | Not described Receives: Other: Continuous Phototherapy with a irradiance of 40 µW/cm2/nm from the overhead light |
| 12 hours continuous double phototherapy with irradiance of over head light of 55 µW/cm2/nm | Active comparator | Not described Receives: Other: Continuos Phototherapy with a irradiance of 55 µW/cm2/nm from the overhead light |
| 12 hours continuous double phototherapy with irradiance of over head light of 70 µW/cm2/nm | Active comparator | Not described Receives: Other: Continuous Phototherapy with a irradiance of 70 µW/cm2/nm from the overhead light |
| 12 hours cycled double phototherapy with irradiance of over head light of 70 µW/cm2/nm | Active comparator | This group will receive 12 hours double phototherapy in cycles of 1,5 hours. Thus receiving 1,5 hours treatment, 1,5 hours pause, 1,5 hours treatment etc. Receives: Other: Cycled phototherapy with a irradiance of 70 µW/cm2/nm from the overhead light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total serum bilirubin
Measured: At 12 hours from initiated treatment
Secondary outcomes (2)
Re-admissions to the hospital
Measured: 14 days after initiation of treatment the patient's file will be examined to determine, if relapse of the conidition has occured
Breast feeding or formula
A description of the newborn's nutrition will be noted comparing cycled and continuous phototherapy. This is relevant because in continuous (standard) treatment the infant spends longer periods away from the parent thus making the establishment of breast feeding more difficult
Measured: At the initiation and immediately after treatment, as well as during a follow-up telephone call 4 months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start14 Jan 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2029 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All infants will receive 12 hours double therapy with a biliblanket and overhead light providing an intensity of either 40-, 55- or 70 µW/cm2/nm. Three groups will be treated with continuous phototherapy while a fourth group will receive intermittent phototherapy of 1,5 hours cycled intervals with an intensity of 70 µW/cm2/nm.
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regionshospital Nordjylland
- Sponsor type
- Other government
- Collaborators
- Aalborg University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702241
- Sponsor's protocol ID
- N-20240019
- Other IDs
- F2024-032
- Status last verified
- Nov 2025
- First submitted
- 6 Nov 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is stated in the approval from the ethical comittee that no person outsite the project might gain knowledge or insight in IPD
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Hyperbilirubinemia - Phototherapeutic Treatment Strategies
- ClinicalTrials.gov ID
- NCT06702241
- Acronym / sponsor ID
- N-20240019
- Conditions
- Neonatal Hyperbilirubinemia
- Keywords
- Cycled phototherapy, high irradiance phototherapy, Neonatal jaundice, Newborn jaundice, neonatal hyperbilirubinemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Regionshospital NordjyllandOther government
- Collaborators
- Aalborg University Hospital
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 22 Nov 2024 (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.
Background Neonatal jaundice affects about 60% of full-term newborns in their first week. If untreated, it can lead to permanent brain damage. In Denmark, 2-5% of newborns require phototherapy, the standard treatment. The maximum beneficial irradiance limit for phototherapy remains unclear. Furthermore, studies suggest that cycled phototherapy is as effective as continuous treatment.
This study aims to investigate the efficacy of elevating the irradiance of intensive phototherapy treatment regimens. This is to evaluate the dose-response relationship. Furthermore, the study aims to compare intermittent phototherapy to continuous phototherapy.
Methods:
In a clinical randomized multicenter trial 116 newborns with non-hemolytic hyperbilirubinemia, gestational age >33+0, weight >1800g and no other significant neonatal diagnose will be randomized. All infants will receive 12 hours double therapy with a biliblanket and overhead light providing an intensity of either 40-, 55- or 70 µW/cm2/nm. Three groups will be treated with continuous phototherapy while a fourth group will receive intermittent phototherapy of 1,5 hours cycled intervals with an intensity of 70 µW/cm2/nm.
Parental experiences during treatment will be examined through a survey post treatment.
The study has been approved by the Regional Research Ethics Committee.
Perspectives:
Understanding the dose-response relationship of phototherapy will give an insight in the most effective way of treating neonatal jaundice. Intermittent therapy, if proven non-inferior, could facilitate more intimacy in the parent-infant relationship as well as benefits in initiating breastfeeding
Detailed description
A randomized clinical study is planned to determine whether there is an upper limit to the efficacy of phototherapy irradiance and whether intermittent/cyclic treatment is as effective as continuous treatment. The study will be conducted at the Maternity Ward and the Department of Pediatrics and Adolescents at the North Denmark Regional Hospital, as well as the Neonatal Department at Aalborg University Hospital. Power calculations require the inclusion of 29 children in each of the four groups, totaling 116 children.
Inclusion criteria are newborns born at ≥33+0 weeks of gestation and a birth weight of ≥1800 g, with a blood bilirubin level above the treatment threshold as specified in the national guidelines. Newborns with rapidly rising bilirubin levels, indicating the need for more intensive treatment with light from multiple sides, exchange transfusion, or possibly immunoglobulin, are excluded from the study.
All children will be treated with double light-overhead light and a light blanket-for 12 hours. The included children will be randomized into one of four groups, each with a specific irradiance level for overhead phototherapy: 40, 55, and 70 µW/cm²/nm. The light blanket under the child will provide an irradiance of 30 µW/cm²/nm. The 70 µW/cm²/nm group will be divided into two subgroups: continuous and intermittent treatment. Thus, there will be four groups in total. Irradiance can be measured and practically adjusted by modifying the distance between the child and the light source. For intermittent treatment, a strategy of 1.5 hours of phototherapy followed by a 1.5-hour pause will be used, based on experiences from other studies and to accommodate the family's and child's feeding needs.
The primary outcome is the reduction in total serum bilirubin, measured from the start of treatment to after 12 hours. Secondary outcomes will include recording whether any children experience a rebound increase in bilirubin. This will be done by reviewing the medical records of the included children to determine if a new blood test for serum bilirubin has been performed, indicating a rebound.
The children will be closely monitored for signs of early bilirubin encephalopathy through medical examinations, weight control, and records of food intake (either breast milk or formula). Serum bilirubin will be measured before the start of treatment. After 12 hours of treatment, serum bilirubin, hemoglobin, and photoisomers will be measured. Serum bilirubin must be measured no more than three hours before the start of phototherapy.
Data analysis will examine:
Differences between the three groups with varying light intensities. Differences between the two groups with the same irradiance but differing treatment regimens (intermittent vs. continuous).
Parents of children meeting the inclusion criteria will be presented with the project verbally and in writing by department staff in a quiet, undisturbed setting. Parents will have time to consider the project while awaiting blood test results and preparing for phototherapy. If parents cannot agree or decide, the child will not participate in the project.
The project is registered with the Research Projects Registry of the North Denmark Region (ID: F2024-032). The project is approved by the Danish Scientific Ethical Committee for Region North Jutland, registration number N-20240019.
Perspectives The study aims to enable more effective and shorter treatment for the 2-5% of all newborns receiving phototherapy. This will allow for more time to establish breastfeeding and bonding between the child and parent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- All infants will receive 12 hours double therapy with a biliblanket and overhead light providing an intensity of either 40-, 55- or 70 µW/cm2/nm. Three groups will be treated with continuous phototherapy while a fourth group will receive intermittent phototherapy of 1,5 hours cycled intervals with an intensity of 70 µW/cm2/nm.
| Arm | Type | Receives |
|---|---|---|
| 12 hours continuous double phototherapy with irradiance of over head light of 40 µW/cm2/nm | Active comparator | Other: Continuous Phototherapy with a irradiance of 40 µW/cm2/nm from the overhead light |
| 12 hours continuous double phototherapy with irradiance of over head light of 55 µW/cm2/nm | Active comparator | Other: Continuos Phototherapy with a irradiance of 55 µW/cm2/nm from the overhead light |
| 12 hours continuous double phototherapy with irradiance of over head light of 70 µW/cm2/nm | Active comparator | Other: Continuous Phototherapy with a irradiance of 70 µW/cm2/nm from the overhead light |
| 12 hours cycled double phototherapy with irradiance of over head light of 70 µW/cm2/nm | Active comparator | Other: Cycled phototherapy with a irradiance of 70 µW/cm2/nm from the overhead lightThis group will receive 12 hours double phototherapy in cycles of 1,5 hours. Thus receiving 1,5 hours treatment, 1,5 hours pause, 1,5 hours treatment etc. |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Hyperbilirubinemia with a total serum bilirubin level above the limit of necessary treatment according to the Danish Pediatric Society's guidelines
- Birth weight >1800g
- Gestational age >33+0
Key exclusion criteria (2 listed)
- Hyperbilirubinemia within the first 24 hours of life
- Rapidly increasing serum levels of bilirubnemia indicating pathology or hemolysis
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 |
|---|---|---|
| Continuous Phototherapy with a irradiance of 40 µW/cm2/nm from the overhead lightThe difference in irradiance between the groups will be measured with a radiometer specific to the device's wavelength. | Other | 12 hours continuous double phototherapy with irradiance of over head light of 40 µW/cm2/nm |
| Continuos Phototherapy with a irradiance of 55 µW/cm2/nm from the overhead lightThe difference in irradiance between the groups will be measured with a radiometer specific for the device's wavelenght | Other | 12 hours continuous double phototherapy with irradiance of over head light of 55 µW/cm2/nm |
| Continuous Phototherapy with a irradiance of 70 µW/cm2/nm from the overhead lightThe difference in irradiance between the groups will be measured with a radiometer specific for the device's wavelenght | Other | 12 hours continuous double phototherapy with irradiance of over head light of 70 µW/cm2/nm |
| Cycled phototherapy with a irradiance of 70 µW/cm2/nm from the overhead lightThe difference in irradiance between the groups will be measured with a radiometer specific for the device's wavelenght | Other | 12 hours cycled double phototherapy with irradiance of over head light of 70 µW/cm2/nm |
Primary outcome
Total serum bilirubin
Time frame: At 12 hours from initiated treatment
2 secondary outcomes
Re-admissions to the hospital
Time frame: 14 days after initiation of treatment the patient's file will be examined to determine, if relapse of the conidition has occured
Breast feeding or formula
Time frame: At the initiation and immediately after treatment, as well as during a follow-up telephone call 4 months later.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No. It is stated in the approval from the ethical comittee that no person outsite the project might gain knowledge or insight in IPD
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Continuous Phototherapy with a irradiance of 40 µW/cm2/nm from the overhead light, Continuos Phototherapy with a irradiance of 55 µW/cm2/nm from the overhead light and Continuous Phototherapy with a irradiance of 70 µW/cm2/nm from the overhead light in people with Neonatal Hyperbilirubinemia, run by Regionshospital Nordjylland at 2 sites in Denmark.
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: looking for participants now, as of the sponsor's last update on 20 Nov 2025. 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 Denmark. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emil L Oehrstroem, MD (+45 24830384, e.oehrstroem@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total serum bilirubin (time frame: At 12 hours from initiated 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 20 Nov 2025.