| CTRI Number |
CTRI/2012/09/003026 [Registered on: 27/09/2012] Trial Registered Retrospectively |
| Last Modified On: |
27/09/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of light intensity doses for effectiveness of phototherapy |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh Agarwal |
| Designation |
Associate Professor |
| Affiliation |
AIIMS |
| Address |
Division OF Neonatology
Department of Pediatrics
AIIMS
New Delhi
South
DELHI
110029
India |
| Phone |
9810756718 |
| Fax |
|
| Email |
ra.aiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Maheshwari |
| Designation |
junior resident |
| Affiliation |
AIIMS |
| Address |
Department of Pediatrics
AIIMS
New Delhi
South
DELHI
110029
India |
| Phone |
9871706838 |
| Fax |
|
| Email |
ankitmahes@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Agarwal |
| Designation |
Associate Professor |
| Affiliation |
AIIMS |
| Address |
Division OF Neonatology
Department of Pediatrics
AIIMS
New Delhi
South
DELHI
110029
India |
| Phone |
9810756718 |
| Fax |
|
| Email |
ra.aiims@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences |
| Address |
AIIMS
Ansari Nagar
New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankit Maheshwari |
All India Institute of Medical Sciences |
NICU-B first floor,new private ward building, AIIMS,Ansari nagar New Delhi
South
DELHI |
9871706838
ankitmahes@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee/Ethics Sub Committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Late preterm and term babies with hyperbilirubinemia,otherwise healthy and breast feeding., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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. |
| Comparator Agent |
Low irradiance |
lower irradiance is around 25 microWatt/cm2/nm.Baby kept under lower level of irradiance.TSB done every 12 hrly till 2 values below cutoff levels. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
• Late Preterm & Term (≥34 weeks and <42 wk)
• Development of jaundice in 1st week with TSB levels requiring phototherapy as per AAP criteria
|
|
| ExclusionCriteria |
| Details |
• Rh haemolytic disease
• Major Congenital Anomalies
• No availability of a working phototherapy unit
• Refusal to consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
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 cessation |
-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 |
|
|
Target Sample Size
|
Total Sample Size="158"
Sample Size from India="158"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/03/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 .
|