Home Phototherapy for Term Newborns With Icterus

Study Overview
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Brief Summary
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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
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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.

Official Title
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Home Phototherapy for Term Newborns With Icterus, a Clinical Randomized Blinded Trial

Conditions
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Neonatal Hyperbilirubinemia

Intervention / Treatment
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* Other: home phototherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 48 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Phototherapy at hospital<br>Newborns with icterus that receive treatment while being admitted to hospital. | |
| Experimental: Home phototherapy<br>Newborns with icterus receiving phototherapy at home. | Other: home phototherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in parent-child bonding | Measured by parents answering the Postpartum Bonding questionnaire. Score range 0-125, higher is worse. | Change from discharge to 4-months after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in parents emotional status | Measured by parents answering the Edinburgh Postnatal DepressionScale (EDPS). Score range 0-30, higher is worse. | 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. | 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. | 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. | 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). | measurements are performed from date of randomization until discharge, assessed up to 4 weeks of age. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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home phototherapy, parental bonding