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Comparison of light intensity doses for effectiveness of phototherapy

Comparison of two irradiance levels for efficacy of phototherapy in LED phototherapy device: A randomized controlled trial in infants at or above 35 weeks GA

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/09/003026
Enrollment
158
Registered
2012-09-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Late preterm and term babies with hyperbilirubinemia,otherwise healthy and breast feeding.

Interventions

Intervention1: Higher irradiance: Higher irradiance is around 45 microwatt/cm2/nm.Baby kept under higher level of irradiance.TSB done every 12 hrly till 2 values below cutoff levels. Control Interven

Sponsors

All India Institute Of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Late Preterm & Term (>=34 weeks and • Development of jaundice in 1st week with TSB levels requiring phototherapy as per AAP criteria

Exclusion criteria

Exclusion criteria: • Rh haemolytic disease • Major Congenital Anomalies • No availability of a working phototherapy unit • Refusal to consent

Design outcomes

Primary

MeasureTime frame
To compare the total duration of phototherapy (O ) in healthy late preterm and term neonates with hyperbilirubinemia during first week of life (P) treated with LED Phototherapy device , high level of irradiance (45±5µW/cm2/nm) (I) compared to low level of irradiance (22.5±5 µW/cm2/nm)Timepoint: the total duration of phototherapy till 2 serum bilirubin values are below cutoff values .

Secondary

MeasureTime frame
To compare the effect of increasing irradiance on: 1. The rate of fall of bilirubin in first 24 hours of initiating phototherapy 2. Incidence of adverse effects (hypothermia or hyperthermia ) during therapy , and 3. Proportion of infants experiencing rebound hyperbilirubinemia requiring re-institution of phototherapy within 24 hrs of its cessationTimepoint: -first 24 hrs- rate of fall of bilirubin -adverse effects during phototherapy -any rebound rise in bilirubin requiring re-phototherapy 24 hrs after stopping phototherapy

Countries

India

Contacts

Public ContactDr Ramesh Agarwal

AIIMS

ankitmahes@gmail.com9871706838

Outcome results

None listed

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