Home Phototherapy for Term Newborns With Icterus

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Hyperbilirubinemia
• Intervention / Treatment: Other: home phototherapy

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 Type: Interventional
• Enrollment (Actual): 147
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Eskilstuna, Sweden
    • Childrens department at Mälarsjukhuset/hospital
  • Falun, Sweden
    • Childrens department Falun hospital
  • Halmstad, Sweden
    • Childrens department Halmstad hospital
  • Karlstad, Sweden
    • Childrens department Karlstad hospital
  • Region Orebro County
    • Örebro, Region Orebro County, Sweden
      • Childrens department University hospital in Örebro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Region Örebro County
• Investigators: Principal Investigator: Mats Eriksson, Professor, Örebro University, Region Örebro County

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2016
• Primary Completion (Actual): June 26, 2019
• Study Completion (Actual): June 26, 2019

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: home phototherapy; parental bonding
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal
• Other Study ID Numbers: 209715

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No