Home Phototherapy for Term Newborns With Icterus

Neonatal Hyperbilirubinemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536078
• Other study ID #: 209715
• Status: Completed
• Phase: N/A
• Start date: June 30, 2016
• Est. completion date: June 26, 2019

Study information

• Verified date: September 2019
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: June 26, 2019
• Est. primary completion date: June 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Neonatal Hyperbilirubinemia

Intervention

Other:
• home phototherapy

Locations

Country	Name	City	State
Sweden	Childrens department at Mälarsjukhuset/hospital	Eskilstuna
Sweden	Childrens department Falun hospital	Falun
Sweden	Childrens department Halmstad hospital	Halmstad
Sweden	Childrens department Karlstad hospital	Karlstad
Sweden	Childrens department University hospital in Örebro	Örebro	Region Orebro County

Sponsors (1)

Lead Sponsor	Collaborator
Region Örebro County

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Parental stress	Measured by parents answering the Swedish Parenthood Stress Questionnaire. Score range 34-170, higher is worse.	at 4 months after discharge
Secondary	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.