| CTRI Number |
CTRI/2018/02/011940 [Registered on: 16/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
16/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparing duration of phototherpy in neonatal jaundice between two different guidelines |
|
Scientific Title of Study
|
A Randomised controlled trial comparing the duration of phototherapy
following NICE(UK) and AAP guidelines in neonatal hyperbilirubinemia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ratan Kumar Biswas |
| Designation |
Post Doctoral trainee |
| Affiliation |
The Institute of Post Graduate Medical Education Research IPGMER |
| Address |
Institute of Post Graduate Medical Education and Research,Kolkata
Department of Neonatology
240 AJC bose road kolkata 700020
Kolkata
WEST BENGAL
712503
India |
| Phone |
9433702671 |
| Fax |
|
| Email |
ratansarmistha2011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Munian |
| Designation |
Assistant Professor |
| Affiliation |
The Institute of Post Graduate Medical Education Research IPGMER |
| Address |
Institute of Post Graduate Medical Education and Research,Kolkata
Department of Neonatology
240 AJC bose road kolkata 700020
Kolkata
WEST BENGAL
700150
India |
| Phone |
9163288916 |
| Fax |
|
| Email |
dr.dineshmunian@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ratan Kumar Biwas |
| Designation |
Post Doctoral trainee |
| Affiliation |
The Institute of Post Graduate Medical Education & Research (IPGMER) |
| Address |
Institute of Post Graduate Medical Education and Research,Kolkata
Department of Neonatology
240 AJC bose road kolkata 700020
Kolkata
WEST BENGAL
712503
India |
| Phone |
9433702671 |
| Fax |
|
| Email |
ratansarmistha2011@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Institute of Post Graduate Medical Education and Research, 244 AJC Bose Road, Kolkata-700020 |
|
|
Primary Sponsor
|
| Name |
IPGMER Kolkata |
| Address |
kolkata,westbengal |
| 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 Ratan Kumar Biswas |
The Institute of Post Graduate Medical Education & Research (IPGME&R), Kolkata |
Department of Neonatology
Kolkata
WEST BENGAL |
9433702671
ratansarmistha2011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER RESEARCH OVERSIGHT COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
icteric newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intervention
one arm comprising of 64 babies who will be chosen randomly for phototherapy by AAP guideline will receive photoyherapy according to the hour specific nomogram.serum bilirubin level will be measured 6hrly initially if it is close to exchange level or till it starts faliing, then it will be measured 12 hrly till serum bilirubin level comes down to 13 mg/ dl when phtotherapy will stopped, rebound hyperbilirubinemia will be checked 24 hrs after stopping phototherapy.Total duration of phototherapy will be calculated by subtracting the difference betwwen starting and end point of phototherapy. |
comparator group:
in this arm 64 babies who will be randomly selected for phototherapy by NICE guideeline will be receiving phototherapy once then crosss the gestational age and hour specific value.Photothedrapy will be stopped once it comes down to more than50 micromol/ltr below the hour and gestational age specific value. This group will also be checked for rebound hyperbilirubinemia 24 hrs after stopping phototherapy.Total duration of phototherapy will be calculated by subtracting the difference betwwen starting and end point of phototherapy. |
| Comparator Agent |
one arm comprising of 64 babies will be chosen randomly for phototherapy by AAP guideline.serum bilirubin level will be measured 6hrly initially if it is close to exchange level or till it starts faliing,then12hrlyor upto 13mg/dlwhen it will be stopped.rebound hyperbilirubinemia will be checked 24 hrs after stopping phototherapy.Total duration of phototherapy will be calculated by subtracting the difference betwwen starting and end point of phototherapy. |
comparator group: in this arm 64 babies who will be randomly selected for phototherapy by NICE guideeline will be receiving phototherapy once then crosss the gestational age and hour specific value.Photothedrapy will be stopped once it comes down to more than50 micromol/ltr below the hour and gestational age specific value. This group will also be checked for rebound hyperbilirubinemia 24 hrs after stopping phototherapy.Total duration of phototherapy will be calculated by subtracting the difference betwwen starting and end point of phototherapy. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
All babies requiring phototherapy for neonatal hyperbilirubinemia between 35-42 weeks of gestational age will be included in the study. |
|
| ExclusionCriteria |
| Details |
a.Any baby having major congenital malformation
b.Babies with haemolytic jaundice |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome variable is duration of phototherapy. |
6hrs,12hrs,24hrs,48hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcome variables are treatment failure and rebound
hyperbilirubinemia. |
6hrs,12 hrs,24 hrs,48 hrs |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
Final Enrollment numbers achieved (Total)= "130"
Final Enrollment numbers achieved (India)="130" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Introuction: Nearly 60% of newborns become clinically jaundiced sometime during the first week of life. 1 In neonatal hyperbilirubinemia which is predominantly unconjugated.Excess production of bilirubin along with hepatic immaturity plays a key role.If uncontrolled this hyperbilirubinemia can lead to kernicterus with its devastating neurodevelopmental outcome.Effective phototherapy reduces the chance of kernicterus drasticallybut in a resource constrained country like India recipients always outnumber resources, thats why a phototherapy protocol with a shorter duration of phtotherapy is of greater importance .Of the guidelines practiced worldwide, AAP 2004 and NICE 2010 neonatal hyperbilirubinemia guidelines are the two most accepted ones for treating jaundiced newborn.Both have set their own starting and end points of treatment, but it is not known whether using one guideline over the other will lead to a longer duration of phototherapy of more incidences of treatment failure or whether more number of babies get treatment unnecessarily by any of these guidelines.Aim:To evaluate whether the AAP guideline is able to treat babies with hyperbilirubinemia with phototherapy for a shorter duration in comparison to the NICE guideline. DESIGN: This is a open labeled, single centre, prospective, randomized controlled trial .128 consecutively born babies with neonatal jaundice admitted in NICU of SSKM and IPGMER hospital, Kolkata during the study period will be included in the study after their parents have given informed consent in writing.Babies with major congenital malformtion and hemolytic jaundice will be be excluded from the studyHere after all such babies will be randomized into 2 groups. The control group comprising of 64 babies will continue to receive phototherapy by AAP guideline whereas the other group comprising of 64 babies will receive phototherapy in accordance to NICE 2010 guideline.Both the groups will receive phototherapy by LED phottherapy unit. Babies will be followed up for rebound hyperbilirunemia ,hearing impairment and neurological examination when they reach gestaional age of 40 weeks Direct coomb test, reticulocyte count , G-6 PD level will be estimated to ascertain treatment failure.
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