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
Study website
Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Hospital
Study 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
Pharmaceutical study type(s)
Phase
Drug/device/biological/vaccine name(s)
Primary outcome measure
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 study start date
02/09/2011
Overall study end date
01/08/2013
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Neonate
Sex
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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|