CTRI Number |
CTRI/2024/06/068787 [Registered on: 12/06/2024] Trial Registered Prospectively |
Last Modified On: |
12/06/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Other (Specify) [PHOTOTHERAPY] |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Alternative (Intermittent) Vs Standard (Continous) Treatment (Phototherapy) Methods For Jaundice in Newborns |
Scientific Title of Study
|
Intermittent versus Continuous phototherapy for neonatal nonhemolytic hyperbilirubinemia in neonates 28 to 34 weeks of gestational age A non inferiority randomized control trial. |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Ishita Singh |
Designation |
DM Neonatology Senior Resident |
Affiliation |
Sri Ramachandra Medical College |
Address |
Department of Neonatology
3rd Floor
Sri Ramachandra Medical College
Chennai TAMIL NADU 600056 India |
Phone |
8376890569 |
Fax |
|
Email |
ishitarameshsingh@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Prakash Amboiram |
Designation |
Professor |
Affiliation |
Sri Ramachandra Medical College |
Address |
Department of Neonatology
3rd Floor
Sri Ramachandra Medical College
Chennai TAMIL NADU 600056 India |
Phone |
|
Fax |
|
Email |
draprakash1@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Ishita Singh |
Designation |
DM Neonatology Senior Resident |
Affiliation |
Sri Ramachandra Medical College |
Address |
Department of Neonatology
3rd floor
Sri Ramachandra Medical College
Chennai TAMIL NADU 600056 India |
Phone |
|
Fax |
|
Email |
ishitarameshsingh@gmail.com |
|
Source of Monetary or Material Support
|
Sri Ramachandra Medical College, No 1 Ramachandra Nagar, Porur, Chennai, 60016- Tamil Nadu, India |
|
Primary Sponsor
|
Name |
Sri Ramachandra Medical College Porur |
Address |
Sri Ramachandra Medical College, Porur Chennai Tamil Nadu 600056 |
Type of Sponsor |
Private medical college |
|
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 Ishita Singh |
Sri Ramachandra Medica College, Chennai |
Neonatal Intensive Care Unit Chennai TAMIL NADU |
8376890569
ishitarameshsingh@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Research Ethics Commitee (For PG Students Of Medical College) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: P599||Neonatal jaundice, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Continous phototherapy |
To be given for 24 hours continuously. Followed by serum bilirubin assessment |
Intervention |
Intermittent Phototherapy |
Timed,6hourly interrupted phototherapy for neonatal phototherapy-
To be given for 12-24 hours till resolution of jaundice i.e. Serum Bilirubin falls below phototherapy cut off |
|
Inclusion Criteria
|
Age From |
0.00 Day(s) |
Age To |
28.00 Day(s) |
Gender |
Both |
Details |
Neonates 28- 34 weeks gestation with non-hemolytic jaundice |
|
ExclusionCriteria |
Details |
Septic Shock with systemic instability
Major congenital and chromosomal anomalies
Severe IVH
Culture proven Meningitis
Babies on phototherapy for indication other than hyperbilirubinenemia
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
The rate of fall of serum bilirubin values during the treatment duration |
From the time of starting Phototherapy to 24 hours after |
|
Secondary Outcome
|
Outcome |
TimePoints |
I. Duration of Phototherapy received to treat non hemolytic hyperbilirubinemia
II. Incidence of “IPT Non respondersâ€
III. KMC duration
IV. Weight loss patterns
V. Feed intolerance
VI. Nurse Satisfaction Score
VII. Newborn Skin Condition Scores
|
I. At end of study
II. At end of study period
III. Daily
IV. Daily
V. Daily
VI. One time during treatment period
VII. One time after receiving cumulative at least 24 hours of phototherapy
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
24/06/2024 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Neonatal jaundice occurs in 60% term and 80% preterm infants. Continuous Phototherapy(CPT) reduces kernicterus and improves neurodevelopmental outcomes across all gestations. However alterations in mesenteric, cerebral blood flow, DNA damage, risk of carcinogenesis and higher mortality in ELBW babies have been reported. Intermittent Phototherapy(IPT) is a proven non-inferior alternative to CPT in Term and Late Preterm babies. CTRI Registration will be done and the study will be conducted from April 2023-December 2024. With 80 % power and an alpha error of 5 % that indicated intermittent PT is not inferior to continuous PT in terms of rate of fall of bilirubin, 45 neonates will be enrolled in each group with the help of computer generated randomisation. Infants with gestations 28 – 34 weeks of gestations with nonhemolytic hyperbilirubinemia during NICU stay will be enrolled with infants in IPT group receiving phototherapy for 6 hour cycles. While infants in CPT group will receive phototherapy for 24 hours. Total serum bilirubin (TSB) will be done every 12- 24 h in both groups until criteria for stopping PT is met. Primary outcomes will be -Rate of fall of bilirubin. Data will be presented as number and percentage, mean and standard deviation or median and interquartile range as appropriate. Relevant tests of significance will be applied. Multiple regression analysis will be used to adjust for confounding. p value of <0.05 will be considered statistically significant Intermittent phototherapy may possibly avoid cerebral, splanchnic hemodynamic fluctuations in VLBW infants with preserved skin integrity. Improved KMC hours, decreased mother infant separation can be gained in infants between 28-34 weeks gestation. Finally, it may help NICU to treat more babies with limited phototherapy units across all gestations. |