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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
Sponsor:
Information provided by (Responsible Party):
Region Örebro County

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.


Condition or disease Intervention/treatment Phase
Neonatal Hyperbilirubinemia Other: home phototherapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Group allocation blinded to the investigator.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Miriam Pettersson, MD +46 19 6023491 miriam.pettersson@regionorebrolan.se

Locations
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Sweden
Childrens department at Mälarsjukhuset/hospital Not yet recruiting
Eskilstuna, Sweden
Contact: Katarina Strand Brodd, MD    +46 16-10 30 00    katarina.strand.brodd@dll.se   
Childrens department Falun hospital Recruiting
Falun, Sweden
Contact: Andreas Odlind, MD    +46 23 49 00 00    andreas.odlind@ltdalarna.se   
Childrens department Halmstad hospital Recruiting
Halmstad, Sweden
Contact: Anna Kasemo, MD    +46 35 13 10 00    Anna.Kasemo@regionhalland.se   
Childrens department Karlstad hospital Recruiting
Karlstad, Sweden
Contact: Eva Albinsson, MD    +46 54 61 50 00    eva.albinsson@liv.se   
Childrens department University hospital in Örebro Recruiting
Örebro, Sweden
Contact: Miriam Pettersson, MD    +46 19 6023491    miriam.pettersson@regionorebrolan.se   
Sponsors and Collaborators
Region Örebro County
Investigators
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Principal Investigator: Mats Eriksson, Professor Örebro University

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Responsible Party: Region Örebro County
ClinicalTrials.gov Identifier: NCT03536078     History of Changes
Other Study ID Numbers: 15RS4948
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Region Örebro County:
home phototherapy
parental bonding

Additional relevant MeSH terms:
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Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Pathologic Processes
Infant, Newborn, Diseases