Clinical trial NCT03536078: Home Phototherapy for Term Newborns With Icterus
Official title: Home Phototherapy for Term Newborns With Icterus, a Clinical Randomized Blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Hyperbilirubinemia
Keywords: home phototherapy
parental bonding
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 147
Sex: ALL
Minimum age (years): 48
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in parent-child bonding
timeFrame: Change from discharge to 4-months after discharge
Secondary outcomes:
measure: Change in parents emotional status
timeFrame: Change from discharge to 4 months after discharge
measure: Change in health-related Life quality
timeFrame: Change from discharge to 4 months after discharge
measure: Change in mothers experience of breastfeeding
timeFrame: Change from discharge to 4 months after discharge
measure: Parental stress
timeFrame: at 4 months after discharge
measure: Transcutaneous bilirubin measurement, and how it is affected by phototherapy
timeFrame: measurements are performed from date of randomization until discharge, assessed up to 4 weeks of age.
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Childrens department University hospital in Örebro
state: Region Orebro County
city: Eskilstuna
country: Sweden
facility: Childrens department at Mälarsjukhuset/hospital
city: Falun
country: Sweden
facility: Childrens department Falun hospital
city: Halmstad
country: Sweden
facility: Childrens department Halmstad hospital
city: Karlstad
country: Sweden
facility: Childrens department Karlstad hospital
Study officials:
affiliation: Örebro university, Region Orebro County
name: Mats Eriksson, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.