Comparison of light intensity doses for effectiveness of phototherapy

Recruiting

• Conditions: Late preterm and term babies with hyperbilirubinemia,otherwise healthy and breast feeding.

• Registration Number: CTRI/2012/09/003026
• Lead Sponsor: All India Institute Of Medical Sciences

Brief Summary

)Jaundice is a very common problem in neonates and phototherapy is a safe, effective and first line of management .There are very less studies working with higher level of irradiance(doses of light intensity) for effectiveness of phototherapy. our study hypothesis is that increasing the irradiance of phototherapy will increase the efficacy of phototherapy in terms of total duration of phototherapy and rate of fall of bilirubin, at the same time looking out any adverse effect of higher irradiance .

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-26
• Last Update Posted: 2012-09-27

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

•Late Preterm & Term (≥34 weeks and <42 wk) •Development of jaundice in 1st week with TSB levels requiring phototherapy as per AAP criteria.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	the total duration of phototherapy till 2 serum bilirubin values are below cutoff values .

Secondary Outcome Measures

Name	Time	Method
To compare the effect of increasing irradiance on:	1.The rate of fall of bilirubin in first 24 hours of initiating phototherapy

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 South, DELHI, India

All India Institute of Medical Sciences

🇮🇳South, DELHI, India

Dr Ankit Maheshwari

Principal investigator

9871706838

ankitmahes@gmail.com