Home Phototherapy for Term Newborns With Icterus
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|ClinicalTrials.gov Identifier: NCT03536078|
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : May 24, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Hyperbilirubinemia||Other: home phototherapy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||Group allocation blinded to the investigator.|
|Official Title:||Home Phototherapy for Term Newborns With Icterus, a Clinical Randomized Blinded Trial|
|Actual Study Start Date :||June 30, 2016|
|Estimated Primary Completion Date :||December 10, 2020|
|Estimated Study Completion Date :||June 10, 2021|
No Intervention: Phototherapy at hospital
Newborns with icterus that receive treatment while being admitted to hospital.
Experimental: Home phototherapy
Newborns with icterus receiving phototherapy at home.
Other: home phototherapy
- 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.
- Change in parents emotional status [ Time Frame: Change from discharge to 4 months after discharge ]Measured by parents answering the Edinburgh Postnatal DepressionScale (EDPS). Score range 0-30, higher is worse.
- Change in health-related Life quality [ Time Frame: Change from discharge to 4 months after discharge ]Measured by parents answering SF-36 (Short Form Health Survey). Score range 36-108, higher is worse.
- Change in mothers experience of breastfeeding [ Time Frame: Change from discharge to 4 months after discharge ]Measured by mothers answering Maternal Breastfeeding Evaluation Scale.(MBES). Score range 30-150, higher is better.
- Parental stress [ Time Frame: at 4 months after discharge ]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 [ Time Frame: measurements are performed from date of randomization until discharge, assessed up to 4 weeks of age. ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536078
|Contact: Miriam Pettersson, MD||+46 19 email@example.com|
|Childrens department at Mälarsjukhuset/hospital||Not yet recruiting|
|Contact: Katarina Strand Brodd, MD +46 16-10 30 00 firstname.lastname@example.org|
|Childrens department Falun hospital||Recruiting|
|Contact: Andreas Odlind, MD +46 23 49 00 00 email@example.com|
|Childrens department Halmstad hospital||Recruiting|
|Contact: Anna Kasemo, MD +46 35 13 10 00 Anna.Kasemo@regionhalland.se|
|Childrens department Karlstad hospital||Recruiting|
|Contact: Eva Albinsson, MD +46 54 61 50 00 firstname.lastname@example.org|
|Childrens department University hospital in Örebro||Recruiting|
|Contact: Miriam Pettersson, MD +46 19 6023491 email@example.com|
|Principal Investigator:||Mats Eriksson, Professor||Örebro University|