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Effectiveness of the blanket model of light emitting diode “BLUI blanket” phototherapy on decreasing serum bilirubin levels in physiological jaundice at gestational age = 35 weeks

The effectiveness of the “BLUI Blanket” light emitting diode phototherapy blanket model against decreased bilirubin in physiological jaundice gestational age = 35 Weeks - a randomised control trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17473621
Enrollment
100
Registered
2023-06-06
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-20

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

Conditions

Neonatal jaundice Pregnancy and Childbirth

Interventions

The trial is a single-center, two-armed, randomized controlled trial. The intervention group will be treated with a BLUI Blanket in the post-natal ward. The control group will have conventional photot

Sponsors

Lembaga Pengelola Dana Pendidikan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Infants with gestational age = 35 weeks and birth weight = 2000 grams (p25) 2. Postnatal age > 24 hours – 14 days 3. No history of birth trauma/cephalhematoma/bleeding 4. Total serum bilirubin levels are 10 and less than19 mg/dl (cut-off value for medium risk infants, gestational age 35-36 6/7 weeks and fit), and radar serum bilirubin total 12 less 22 mg/dl (limit value lower risk infants aged = 38 weeks and fit) 5. Asian race 6. No circulatory disturbances, respiratory disorders, and saturation above 90% 7. The patient's parents/guardians agree to participate in the study and sign an informed consent

Exclusion criteria

Exclusion criteria: 1. Genetic, metabolic disorders, hemolytic anemia (examination of GDS levels, blood group, and rhesus, peripheral blood picture) 2. Infection (clinical fever or hypothermia and increased leukocyte laboratory tests) 3. The direct bilirubin level exceeds 2 mg/dl or 20% of the total serum bilirubin level

Design outcomes

Primary

MeasureTime frame
Bilirubin serum level measured by examination of blood serum at 24 hours after the start of phototherapy

Secondary

MeasureTime frame
Side effects measured by physical examination at 24 hours after the start of phototherapy

Countries

Indonesia

Contacts

Public ContactTubagus Ferdi Fadilah
tubagus.ferdi@ui.ac.id+62 21 566 3232

Outcome results

None listed

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