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Home phototherapy device in a hospital setting

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10318105
Enrollment
74
Registered
2015-04-28
Start date
2011-10-25
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Phototherapy by conventional phototherapy device or PEP Bed phototherapy device

Sponsors

KK Research Centre
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Singapore

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026