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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN10318105 |
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Date of registration:
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28/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Home phototherapy device in a hospital setting
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Scientific title:
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Evaluation of efficacy and safety of PEP Bed home PhotoTherapy device in a hospital setting |
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Date of first enrolment:
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25/10/2011 |
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Target sample size:
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74 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN10318105 |
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Study type:
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Interventional |
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Study design:
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Term and late preterm infants with neonatal jaundice needing phototherapy were randomized to conventional phototherapy or PEP Bed phototherapy. (Treatment)
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Phase:
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Ashwani
Bhatia |
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Address:
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KK Women's and Children's Hospital
100 Bukit Timah Road
218814
Singapore
Singapore |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Exclusion criteria: 1. Infants with jaundice needing double or intense phototherapy
2. Hemolytic Jaundice
3. Blood group incompatibilty
4. Glucose-6-phosphate dehydrogenase deficiency
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neonatal jaundice in term or late preterm infants in the first week of life.
Neonatal Diseases
Neonatal jaundice
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Intervention(s)
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Phototherapy by conventional phototherapy device or PEP Bed phototherapy device
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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KK Women’s and Children’s Hospital
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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