Neonatal HyperbilirubinemiaNCT03536078
Home Phototherapy for Term Newborns With Icterus
A study testing home phototherapy in people with Neonatal Hyperbilirubinemia, run by Region Örebro County at 5 sites in Sweden.
Trial summary
The study is designed as a randomised controlled multicenter study.The primary aim is to investigate if home phototherapy improves parent-child bonding compared to if treatment is performed at the hospital. Read more about this study
- Who is it for?
- Ages 48 hours and older
- Conditions the study is for
- Neonatal Hyperbilirubinemia
- What is being tested?
- home phototherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 5 sitesSweden
- Study dates
- 30 Jun 2016to 26 Jun 2019
- 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 48 hours and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gestational age w36-42.
- Age of newborn 48 hours or more.
- Level of bilirubin 300-400 µmol/l
Who cannot join
- Immunisation. Bilirubin >400 µmol/l. Asphyxia. Ongoing infection, weightloss > 10%, other severe disease, parents who don´t speak Swedish, parents that are not expected to be able to handle the home phototherapy equipment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites
Childrens department at Mälarsjukhuset/hospital
Eskilstuna
Childrens department Falun hospital
Falun
Childrens department Halmstad hospital
Halmstad
Childrens department Karlstad hospital
Karlstad
Childrens department University hospital in Örebro
Örebro, Region Orebro County
About this study
Official title: Home Phototherapy for Term Newborns With Icterus, a Clinical Randomized Blinded Trial
The study is designed as a randomised controlled multicenter study.The primary aim is to investigate if home phototherapy improves parent-child bonding compared to if treatment is performed at the hospital. The investigators will also istudy how home phototherapy is perceived by the parents, impact on breastfeeding and parents stress levels, if the method can be implemented etc.
Patients are included at 5 hospitals in Sweden. The plan is to include 250 term newborns with neonatal icterus at a level that needs phototherapy treatment.
Read the detailed description
Background: Almost half of all newborns develops jaundice, due to elevated levels of bilirubin. If levels are high phototherapy is needed to reduce the levels of bilirubin. Presently most children with neonatal jaundice in Sweden receives phototherapy admitted to hospital. There is fiberoptic equipment available that can be used at home to treat the newborns.
Aim: Primary aim is to investigate if parent-child bonding is improved with home phototherapy compared to phototherapy performed at the hospital.
Method:The study is designed as a randomised controlled multicenter study. Eligible parents and newborns are randomised to either treatment at home or at the hospital. Demographic data about the newborn such as for example apgar score, gender, time of birth etc are registered. At time of discharge parents answers questionnaires such as for example the Postpartum Bonding Questionnaire (PBQ), the Edinburgh Postnatal Depression Scale (EDPS), the Swedish Parenthood Stress Questionnaire etc. Parents experiences from home phototherapy will also be investigated through semistructured interviews.
Parents will asked to answer questionnaires at the time of discharge as well as at 4-months after discharge.
Analysis of data will be performed by using conventional parametric and non-parametric statistical methods.
The results of the study will be reported as scientific articles and as part of a thesis.
- Conditions
- Neonatal Hyperbilirubinemia
- Being tested
- home phototherapy
- Keywords
- home phototherapy, parental bonding
- Medical subject headings
- Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home phototherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Phototherapy at hospital | No intervention | Newborns with icterus that receive treatment while being admitted to hospital. |
| Home phototherapy | Experimental | Newborns with icterus receiving phototherapy at home. Receives: Other: home phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parent-child bonding
Measured by parents answering the Postpartum Bonding questionnaire. Score range 0-125, higher is worse.
Measured: Change from discharge to 4-months after discharge
Secondary outcomes (5)
Change in parents emotional status
Measured by parents answering the Edinburgh Postnatal DepressionScale (EDPS). Score range 0-30, higher is worse.
Measured: Change from discharge to 4 months after discharge
Change in health-related Life quality
Measured by parents answering SF-36 (Short Form Health Survey). Score range 36-108, higher is worse.
Measured: Change from discharge to 4 months after discharge
Change in mothers experience of breastfeeding
Measured by mothers answering Maternal Breastfeeding Evaluation Scale.(MBES). Score range 30-150, higher is better.
Measured: Change from discharge to 4 months after discharge
Parental stress
Measured by parents answering the Swedish Parenthood Stress Questionnaire. Score range 34-170, higher is worse.
Measured: at 4 months after discharge
Transcutaneous bilirubin measurement, and how it is affected by phototherapy
Transcutaneous bilirubin is measured every time a blood sample for bilirubin is checked. The transcutaneous measurements are performed on skin exposed to phototherapy(sternum) and non-exposed skin (sacrum).
Measured: measurements are performed from date of randomization until discharge, assessed up to 4 weeks of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start30 Jun 2016
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mats Eriksson, Professor, Principal investigator, Örebro university, Region Orebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536078
- Sponsor's protocol ID
- 209715
- Status last verified
- Sep 2019
- First submitted
- 23 Mar 2018
- Last updated
- 11 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pettersson M, Ryen L, Eriksson M, Ohlin A. The cost-effectiveness of home phototherapy for hyperbilirubinemia in neonates: results from a randomized controlled trial. Sci Rep. 2023 Jul 3;13(1):10727. doi: 10.1038/s41598-023-37684-y.
PubMed 37400561Pettersson M, Eriksson M, Blomberg K. Parental experiences of home phototherapy for neonatal hyperbilirubinemia. J Child Health Care. 2023 Dec;27(4):562-573. doi: 10.1177/13674935221082404. Epub 2022 Mar 26.
PubMed 35341337Pettersson M, Eriksson M, Albinsson E, Ohlin A. Home phototherapy for hyperbilirubinemia in term neonates-an unblinded multicentre randomized controlled trial. Eur J Pediatr. 2021 May;180(5):1603-1610. doi: 10.1007/s00431-021-03932-4. Epub 2021 Jan 19.
PubMed 33469713
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Phototherapy for Term Newborns With Icterus, a Clinical Randomized Blinded Trial
- ClinicalTrials.gov ID
- NCT03536078
- Acronym / sponsor ID
- 209715
- Conditions
- Neonatal Hyperbilirubinemia
- Keywords
- home phototherapy, parental bonding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 24 May 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.
The study is designed as a randomised controlled multicenter study.The primary aim is to investigate if home phototherapy improves parent-child bonding compared to if treatment is performed at the hospital. The investigators will also istudy how home phototherapy is perceived by the parents, impact on breastfeeding and parents stress levels, if the method can be implemented etc.
Patients are included at 5 hospitals in Sweden. The plan is to include 250 term newborns with neonatal icterus at a level that needs phototherapy treatment.
Detailed description
Background: Almost half of all newborns develops jaundice, due to elevated levels of bilirubin. If levels are high phototherapy is needed to reduce the levels of bilirubin. Presently most children with neonatal jaundice in Sweden receives phototherapy admitted to hospital. There is fiberoptic equipment available that can be used at home to treat the newborns.
Aim: Primary aim is to investigate if parent-child bonding is improved with home phototherapy compared to phototherapy performed at the hospital.
Method:The study is designed as a randomised controlled multicenter study. Eligible parents and newborns are randomised to either treatment at home or at the hospital. Demographic data about the newborn such as for example apgar score, gender, time of birth etc are registered. At time of discharge parents answers questionnaires such as for example the Postpartum Bonding Questionnaire (PBQ), the Edinburgh Postnatal Depression Scale (EDPS), the Swedish Parenthood Stress Questionnaire etc. Parents experiences from home phototherapy will also be investigated through semistructured interviews.
Parents will asked to answer questionnaires at the time of discharge as well as at 4-months after discharge.
Analysis of data will be performed by using conventional parametric and non-parametric statistical methods.
The results of the study will be reported as scientific articles and as part of a thesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phototherapy at hospital | No intervention | –Newborns with icterus that receive treatment while being admitted to hospital. |
| Home phototherapy | Experimental | Other: home phototherapyNewborns with icterus receiving phototherapy at home. |
Who may qualify
- Ages
- 48 hours and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Gestational age w36-42.
- Age of newborn 48 hours or more.
- Level of bilirubin 300-400 µmol/l
Key exclusion criteria (1 listed)
- Immunisation. Bilirubin >400 µmol/l. Asphyxia. Ongoing infection, weightloss > 10%, other severe disease, parents who don´t speak Swedish, parents that are not expected to be able to handle the home phototherapy equipment
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 |
|---|---|---|
| home phototherapy | Other | Home phototherapy |
Primary outcome
Change in parent-child bonding
Time frame: Change from discharge to 4-months after discharge
Measured by parents answering the Postpartum Bonding questionnaire. Score range 0-125, higher is worse.
5 secondary outcomes
Change in parents emotional status
Time frame: Change from discharge to 4 months after discharge
Change in health-related Life quality
Time frame: Change from discharge to 4 months after discharge
Change in mothers experience of breastfeeding
Time frame: Change from discharge to 4 months after discharge
Parental stress
Time frame: at 4 months after discharge
Transcutaneous bilirubin measurement, and how it is affected by phototherapy
Time frame: measurements are performed from date of randomization until discharge, assessed up to 4 weeks of age.
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 11 Mar 2021.
- Derived from this study: PubMed 37400561Pettersson M, Ryen L, Eriksson M, Ohlin A. The cost-effectiveness of home phototherapy for hyperbilirubinemia in neonates: results from a randomized controlled trial. Sci Rep. 2023 Jul 3;13(1):10727. doi: 10.1038/s41598-023-37684-y.
- Derived from this study: PubMed 35341337Pettersson M, Eriksson M, Blomberg K. Parental experiences of home phototherapy for neonatal hyperbilirubinemia. J Child Health Care. 2023 Dec;27(4):562-573. doi: 10.1177/13674935221082404. Epub 2022 Mar 26.
- Derived from this study: PubMed 33469713Pettersson M, Eriksson M, Albinsson E, Ohlin A. Home phototherapy for hyperbilirubinemia in term neonates-an unblinded multicentre randomized controlled trial. Eur J Pediatr. 2021 May;180(5):1603-1610. doi: 10.1007/s00431-021-03932-4. Epub 2021 Jan 19.
- 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.
Mats Eriksson, Professor principal investigator
Örebro university, Region Orebro County
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home phototherapy in people with Neonatal Hyperbilirubinemia, run by Region Örebro County at 5 sites in Sweden.
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 1 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 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. 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 parent-child bonding (time frame: Change from discharge to 4-months after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03536078, which also lists 3 linked publications.
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 11 Mar 2021.