Condition category
Neonatal Diseases
Date applied
04/04/2015
Date assigned
28/04/2015
Last edited
28/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Jaundice in new-born infants is a common condition caused by excess of bilirubin in the body. Jaundice affects more than half of all new-born infants and many of them require phototherapy. Phototherapy helps get rid of excess of bilirubin. Jaundiced infants needing phototherapy have to either stay longer in the hospital or go back to hospital. Hospitalisation is expensive and disrupts breast-feeding and infant-mother bonding. Many paediatricians have been recommending home phototherapy to avoid hospitalization. The aim of the study is to assess how well a phototherapy device (PEP Bed) works in hospital before we recommend it for use at home.

Who can participate?
Term and near- term infants with onset of jaundice in the first week of life and needing phototherapy.

What does the study involve?
Participants are randomly allocated to one of two groups: conventional phototherapy or phototherapy with PEP bed device. Although PEP Bed phototherapy device is designed for home use, in this study phototherapy is provided in the hospital itself. Serum bilirubin levels and duration of phototherapy are measured. Babies are monitored for any side effects of phototherapy including skin rash, dehydration, temperature variation or eye discharge. Headache, irritability, eye glare and giddiness are also noted.

What are the possible benefits and risks of participating?
There are no immediate benefits. However in the future jaundiced infants may be offered the option of home phototherapy. This will help establish breast feeding early and affects infant-mother bonding positively. Home phototherapy will also cut down the cost of treatment.
There are no foreseeable risks involved as phototherapy is a safe intervention and has been in use for over 50 years. The possible risk with a new phototherapy device is the infant needing phototherapy for a longer duration if the device is less effective. Infants on any type of phototherapy are at risk of temperature variation, they may have increased water loss from skin and may develop a temporary skin rash.

Where is the study run from?
KK Women’s and Children’s Hospital, Singapore.

When is the study starting and how long is it expected to run for?
September 2011 to August l 2013.

Who is funding the study?
Two new phototherapy devices made available by United BMEC Pte Ltd, Singapore.

Who is the main contact?
Dr Ashwani Bhatia

Trial website

Contact information

Type

Scientific

Primary contact

Evaluation of efficacy and safety of PEP Bed home phototherapy device in the hospital setting Ashwani Bhatia

ORCID ID

Contact details

KK Women's and Children's Hospital
100 Bukit Timah Road
Singapore
218814
Singapore

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evaluation of efficacy and safety of PEP Bed home PhotoTherapy device in a hospital setting

Acronym

PEPBed PT

Study hypothesis

How effective and safe is the use of home phototherapy device in comparison to a conventional phototherapy device?

Ethics approval

SingHealth Centralised Institutional Review Board, 02/09/2011, reference 2010/680/E

Study design

Term and late preterm infants with neonatal jaundice needing phototherapy were randomized to conventional phototherapy or PEP Bed phototherapy.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Neonatal jaundice in term or late preterm infants in the first week of life.

Intervention

Phototherapy by conventional phototherapy device or PEP Bed phototherapy device

Intervention type

Device

Phase

Drug names

Primary outcome measures

Rate of decline in serum bilirubin (SB) level.
SB levels were taken up to 12 times hourly until the level was at or below “Off-Phototherapy” level. Rate of decline in SB was measured in each neonate by dividing the difference in levels of SB by hours of phototherapy given to the neonate. For example, case 1 had SB1 (230µmol/L) at the start of phototherapy, SB2 (195µmol/L) after 12 hours (Phototherapy continued) and SB3 (180µmol/L) level was below Off-Phototherapy level. Phototherapy was discontinued after 24 hours. Rate of decline in SB in this case is SB1-SB3 divided by 24 i.e., 230-180 divided by 24 = 2.08µmol/L/hour.

Secondary outcome measures

Duration of phototherapy.
The nurses looking after the neonates were asked to feedback on their personal experience on a Likert scale whether they experienced any headache, irritability, giddiness, vertigo, eye glare or nausea.

Overall trial start date

02/09/2011

Overall trial end date

01/08/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Term or late preterm (gestational age 35 weeks or more, birthweight 2000 to 4000 grams) with onset of neonatal jaundice on day 2 to day 7 of life and needing single blue phototherapy.

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

74

Participant exclusion criteria

1. Infants with jaundice needing double or intense phototherapy
2. Hemolytic Jaundice
3. Blood group incompatibilty
4. Glucose-6-phosphate dehydrogenase deficiency

Recruitment start date

25/10/2011

Recruitment end date

15/04/2012

Locations

Countries of recruitment

Singapore

Trial participating centre

KK Women's and Children's Hospital
100 Bukit Timah Road
229899
Singapore

Sponsor information

Organisation

KK Research Centre

Sponsor details

100 Bukit Timah Road
Singapore
218814
Singapore

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

KK Women’s and Children’s Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Pllan to submit our study for publication in Annals of Medicine, Singapore

Intention to publish date

31/12/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes