NCT03536078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2019

Completed
Last Updated

March 11, 2021

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

March 23, 2018

Last Update Submit

March 10, 2021

Conditions

Neonatal Hyperbilirubinemia

Keywords

home phototherapyparental bonding

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in parents emotional status

    Change from discharge to 4 months after discharge

  • Change in health-related Life quality

    Change from discharge to 4 months after discharge

  • Change in mothers experience of breastfeeding

    Change from discharge to 4 months after discharge

  • Parental stress

    at 4 months after discharge

  • Transcutaneous bilirubin measurement, and how it is affected by phototherapy

    measurements are performed from date of randomization until discharge, assessed up to 4 weeks of age.

Study Arms (2)

Phototherapy at hospital

NO INTERVENTION

Newborns with icterus that receive treatment while being admitted to hospital.

Home phototherapy

EXPERIMENTAL

Newborns with icterus receiving phototherapy at home.

Other: home phototherapy

Interventions

home phototherapyOTHER
Home phototherapy

Eligibility Criteria

Age48 Hours+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Gestational age w36-42.
  • Age of newborn 48 hours or more.
  • Level of bilirubin 300-400 µmol/l

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Childrens department University hospital in Örebro

Örebro, Region Orebro County, Sweden

Location

Childrens department at Mälarsjukhuset/hospital

Eskilstuna, Sweden

Location

Childrens department Falun hospital

Falun, Sweden

Location

Childrens department Halmstad hospital

Halmstad, Sweden

Location

Childrens department Karlstad hospital

Karlstad, Sweden

Location

Related Publications (3)

  • Pettersson M, Ryen L, Eriksson M, Ohlin A. The cost-effectiveness of home phototherapy for hyperbilirubinemia in neonates: results from a randomized controlled trial. Sci Rep. 2023 Jul 3;13(1):10727. doi: 10.1038/s41598-023-37684-y.

    PMID: 37400561DERIVED

  • Pettersson M, Eriksson M, Blomberg K. Parental experiences of home phototherapy for neonatal hyperbilirubinemia. J Child Health Care. 2023 Dec;27(4):562-573. doi: 10.1177/13674935221082404. Epub 2022 Mar 26.

    PMID: 35341337DERIVED

  • 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.

    PMID: 33469713DERIVED

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mats Eriksson, Professor

    Örebro university, Region Orebro County

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Group allocation blinded to the investigator.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2018

First Posted

May 24, 2018

Study Start

June 30, 2016

Primary Completion

June 26, 2019

Study Completion

June 26, 2019

Last Updated

March 11, 2021

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(5)