| CTRI Number |
CTRI/2024/12/078712 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
25/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical monitoring based bilirubin assessment versus routine bilirubin assessment in neonates with ABO incompatibility |
|
Scientific Title of Study
|
Clinical monitoring based bilirubin assessment versus routine bilirubin assessment in neonates with ABO incompatibility.A randomized controlled 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 |
Ameyaarjun Arumugam |
| Designation |
PG STUDENT |
| Affiliation |
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF PAEDIATRICS,CHETTINAD HOSPITAL AND RESEARCH INSTITUTE,KELAMBAKKAM,CHENNAI,TAMILNADU
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
|
| Fax |
|
| Email |
ameyaarjunarumugam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Giridhar S |
| Designation |
Professor and Head of Department |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Department of Neonatology,Chettinad Hospital and Research Institute,Kelambakkam,Chennai,Tamilnadu
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9841027228 |
| Fax |
|
| Email |
giridharsethu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Giridhar S |
| Designation |
Professor and Head of Department |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Department of Neonatology,Chettinad Hospital and Research Institute,Kelambakkam,Chennai,Tamilnadu
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9841027228 |
| Fax |
|
| Email |
giridharsethu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Hospital and Research Institute,Kelambakkam,Chennai 603103,Tamilnadu,India. |
|
|
Primary Sponsor
|
| Name |
Ameyaarjun Arumugam |
| Address |
DEPARTMENT OF PAEDIATRICS,CHETTINAD HOSPITAL AND RESEARCH INSTITUTE,KELAMBAKKAM,CHENNAI 603103,TAMILNADU,INDIA. |
| Type of Sponsor |
Other [Self] |
|
|
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 Giridhar S |
Chettinad Hospital and Research Institute |
C block,Department of Neonatology,Kelambakkam ,Chennai,Tamilnadu
Kancheepuram
TAMIL NADU |
09841027228
giridharsethu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee for Student Research(CARE IHEC-1) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Newborn babies mlore than 35 weeks of gestation who are direct coomb’s test positive at birth due to ABO incompatibility . |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
routine serum bilirubin assessment group |
Routine serum bilirubin levels will be sent within 6-12 hours after birth of the neonates and will be followed up with serial monitoring of serum bilirubin levels every 12hours till 48-72hours of life.
In both the groups if bilirubin levels fall in phototherapy zone according to AAP bilirubin charts 2022 at any point then phototherapy will be initiated.
Along with serum bilirubin levels baseline complete blood counts , peripheral smear , reticulocyte count will be sent at 1st sampling in both the groups and serially monitored if indicated.
After initiating phototherapy serum bilirubin levels will be checked 12-24hours later in both the groups. Rebound rise in bilirubin levels will be checked after 12 hours of stopping phototherapy. |
| Intervention |
visually assessed for jaundice every 12 hours |
Neonates will be visually assessed for jaundice every 12 hours following delivery until discharge. Total serum bilirubin should be measured as soon as possible for infants noted to be jaundiced ( icterus upto face within 1st 24hrs and upto abdomen within 24-48hrs after birth ). If neonate remains non icteric then routine bilirubin levels will be done after 48 hrs before discharge |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Newborn babies ≥35 weeks of gestation who are direct coomb’s test positive at birth due to ABO incompatibility |
|
| ExclusionCriteria |
| Details |
1.Neonates less than 35 weeks gestation , Neonates with major congenital malformations or syndromic features,Neonates who require extensive resuscitation at birth,Neonates who require immediate NICU stay with advanced life support, Neonates who have features of hydrops fetalis on antenatal scans & required Intrauterine Transfusions, Neonates whose parents haven’t given consent for including in the study ,Neonates with perinatal asphyxia,acute cord vascular accident,Severe SGA neonates |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Need for phototherapy |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Neonates with sepsis
|
1 year |
| Neonates with peak bilirubin levels reaching close to exchange transfusion zone |
1 year |
| Total duration of phototherapy |
1 year |
| Neonates requiring IVIG therapy |
1 year |
| Neonates requiring exchange transfusion |
1 year |
| Length of hospital stay |
1 year |
| Rebound hyperbilirubinemia in neonates treated with phototherapy |
1 year |
| Readmission to hospital |
1 year |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
07/01/2025 |
| 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
|
This study is a randomized,open labelled,parallel group study comparing outcomes in newborns with clinical assessment of jaundice and regular monitoring of bilirubin levels in direct coombs test(DCT) positive infants so that if comparable outcomes are seen in visually inspected infants number of pricks can be decreased.The findings from this study have the potential to eliminate frequent sampling for monitoring of bilirubin levels and can help to alleviate parental anxiety.It gives us a clear picture on the recommended frequency of monitoring without causing any adverse events like significant hyperbilirubinemia causing neurological dysfunction or exchange transfusion. |