Skip to main content
OpenTrials
Completed

NCT Number: NCT03536078

Home Phototherapy for Term Newborns With Icterus

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neonatal Hyperbilirubinemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

48 hour and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Childrens department University hospital in Örebro, Örebro, Region Orebro County, Sweden

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

home phototherapy

Other

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 24, 2018
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.