Home Phototherapy for Term Newborns With Icterus
Primary Purpose
Neonatal Hyperbilirubinemia
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
home phototherapy
Sponsored by
About this trial
This is an interventional treatment trial for Neonatal Hyperbilirubinemia focused on measuring home phototherapy, parental bonding
Eligibility Criteria
Inclusion Criteria:
- Gestational age w36-42.
- Age of newborn 48 hours or more.
- Level of bilirubin 300-400 µmol/l
Exclusion Criteria:
- 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
Sites / Locations
- Childrens department University hospital in Örebro
- Childrens department at Mälarsjukhuset/hospital
- Childrens department Falun hospital
- Childrens department Halmstad hospital
- Childrens department Karlstad hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Phototherapy at hospital
Home phototherapy
Arm Description
Newborns with icterus that receive treatment while being admitted to hospital.
Newborns with icterus receiving phototherapy at home.
Outcomes
Primary Outcome Measures
Change in parent-child bonding
Measured by parents answering the Postpartum Bonding questionnaire. Score range 0-125, higher is worse.
Secondary Outcome Measures
Change in parents emotional status
Measured by parents answering the Edinburgh Postnatal DepressionScale (EDPS). Score range 0-30, higher is worse.
Change in health-related Life quality
Measured by parents answering SF-36 (Short Form Health Survey). Score range 36-108, higher is worse.
Change in mothers experience of breastfeeding
Measured by mothers answering Maternal Breastfeeding Evaluation Scale.(MBES). Score range 30-150, higher is better.
Parental stress
Measured by parents answering the Swedish Parenthood Stress Questionnaire. Score range 34-170, higher is worse.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03536078
Brief Title
Home Phototherapy for Term Newborns With Icterus
Official Title
Home Phototherapy for Term Newborns With Icterus, a Clinical Randomized Blinded Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 30, 2016 (Actual)
Primary Completion Date
June 26, 2019 (Actual)
Study Completion Date
June 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Örebro County
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Hyperbilirubinemia
Keywords
home phototherapy, parental bonding
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Group allocation blinded to the investigator.
Allocation
Randomized
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phototherapy at hospital
Arm Type
No Intervention
Arm Description
Newborns with icterus that receive treatment while being admitted to hospital.
Arm Title
Home phototherapy
Arm Type
Experimental
Arm Description
Newborns with icterus receiving phototherapy at home.
Intervention Type
Other
Intervention Name(s)
home phototherapy
Primary Outcome Measure Information:
Title
Change in parent-child bonding
Description
Measured by parents answering the Postpartum Bonding questionnaire. Score range 0-125, higher is worse.
Time Frame
Change from discharge to 4-months after discharge
Secondary Outcome Measure Information:
Title
Change in parents emotional status
Description
Measured by parents answering the Edinburgh Postnatal DepressionScale (EDPS). Score range 0-30, higher is worse.
Time Frame
Change from discharge to 4 months after discharge
Title
Change in health-related Life quality
Description
Measured by parents answering SF-36 (Short Form Health Survey). Score range 36-108, higher is worse.
Time Frame
Change from discharge to 4 months after discharge
Title
Change in mothers experience of breastfeeding
Description
Measured by mothers answering Maternal Breastfeeding Evaluation Scale.(MBES). Score range 30-150, higher is better.
Time Frame
Change from discharge to 4 months after discharge
Title
Parental stress
Description
Measured by parents answering the Swedish Parenthood Stress Questionnaire. Score range 34-170, higher is worse.
Time Frame
at 4 months after discharge
Title
Transcutaneous bilirubin measurement, and how it is affected by phototherapy
Description
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).
Time Frame
measurements are performed from date of randomization until discharge, assessed up to 4 weeks of age.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational age w36-42.
Age of newborn 48 hours or more.
Level of bilirubin 300-400 µmol/l
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mats Eriksson, Professor
Organizational Affiliation
Örebro university, Region Orebro County
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens department University hospital in Örebro
City
Örebro
State/Province
Region Orebro County
Country
Sweden
Facility Name
Childrens department at Mälarsjukhuset/hospital
City
Eskilstuna
Country
Sweden
Facility Name
Childrens department Falun hospital
City
Falun
Country
Sweden
Facility Name
Childrens department Halmstad hospital
City
Halmstad
Country
Sweden
Facility Name
Childrens department Karlstad hospital
City
Karlstad
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33469713
Citation
Pettersson 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.
Results Reference
derived
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Home Phototherapy for Term Newborns With Icterus
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