| CTRI Number |
CTRI/2024/09/074203 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Caffeine can decrease the oxygen therapy in
preterm: a randomised control trial |
|
Scientific Title of Study
|
Caffeine to decrease the oxygen support duration in
moderate and late preterm a randomised 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 |
Dr Aritra Ray |
| Designation |
Consultant |
| Affiliation |
Neotia Getwel Healthcare Centre |
| Address |
SILIGURI, P.O - Matigara ,
Darjiling
WEST BENGAL
P.O - Matigara ,Dist -Darjeeling
Darjiling
WEST BENGAL
734010
India |
| Phone |
9641632917 |
| Fax |
|
| Email |
aritraray.sunny1988@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aritra Ray |
| Designation |
Consultant |
| Affiliation |
Neotia Getwel Healthcare Centre |
| Address |
Siliguri, P.O - Matigara ,
Darjiling
WEST BENGAL
P.O - Matigara ,Dist -Darjeeling
WEST BENGAL
734010
India |
| Phone |
9641632917 |
| Fax |
|
| Email |
aritraray.sunny1988@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aritra Ray |
| Designation |
Consultant |
| Affiliation |
Neotia Getwel Healthcare Centre |
| Address |
Siliguri, P.O - Matigara ,
Darjiling
WEST BENGAL
P.O - Matigara ,Dist -Darjeeling
Darjiling
WEST BENGAL
734010
India |
| Phone |
9641632917 |
| Fax |
|
| Email |
aritraray.sunny1988@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neotia Getwel Healthcare Centre
Department of Neonatology, Division NICU , room no 205 Darjiling WEST BENGAL
Darjiling
WEST BENGAL
|
|
|
Primary Sponsor
|
| Name |
Institute Neotia Getwel Healthcare Centre Dept of Neonatology |
| Address |
Neotia Getwel Healthcare Centre,Siliguri,Darjeeling, WEST BENGAL-734010, INDIA
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Aritra Ray |
Neotia Getwel Healthcare Centre |
Department of Neonatology, Division NICU ,
room no 205
Darjiling
WEST BENGAL
Darjiling
WEST BENGAL |
09641632917
aritraray.sunny1988@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Neotia Getwel Healthcare Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P220||Respiratory distress syndrome of newborn, (2) ICD-10 Condition: P285||Respiratory failure of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conservative therapy |
respiratory support as per requirement & caffeine citrate to be considered only when they develop apnea of prematurity or baby requires invasive ventilation and stopped caffine of apnea resolved or baby extubated for 5 day
|
| Intervention |
Early caffine therapy |
caffine started to every moderate & late preterm neonate with persistant respiratory support for more than 6 hrs and continued till baby is off o2 support |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
14.00 Day(s) |
| Gender |
Both |
| Details |
PMA: 320/7-36 6/7 weeks & PNA less than 14 days
Requiring respiratory support (NPO2,NCPAP,HHHFNC,NIV) for more than 6 hours post birth.
|
|
| ExclusionCriteria |
| Details |
Major congenital abnormality
Renal or hepatic failure
Arrythmias
Babies requiring invasive MV within 6 hrs
Caffeine received previously within 48 hours
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Total duration of oxygen therapy
|
at baseline,1 wk & 2 wk and at discharge
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hs PDA Requiring Treatment |
any time prior to discharge |
Feed Intolerance Requiring more than 12 Hrs Of Interruption Of Feed.
|
any time prior to discharge |
| Frequency Of Intermittent Hypoxia |
at 1 wk& 2 wk &3 wk and at discharge |
| Prevalence of Retinopathy Of Prematurity, Bronchopulmonary Dysplasia, other respiratory Morbidity prior to discharge |
any time prior to discharge |
Anthropometry.
|
At admission & Discharge |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
31/10/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
AIMS AND OBJECTIVES PRIMARY OUTCOME Total duration of oxygen therapy SECONDARY OUTCOMES Hs PDA Requiring Treatment Feed Intolerance Requiring >12 Hrs Of Interruption Of Feed. Frequency Of Intermittent Hypoxia Before Discharge between two groups Anthropometry Prevalence of Retinopathy Of Prematurity, Bronchopulmonary Dysplasia, other respiratory Morbidity prior to discharge (Pneumothorax, PPHN, Requirement Of Surfactant) MATERIALS AND METHODS TITLE- caffeine to decrease oxygen support duration in moderate and late preterm- a randomized control trial TYPE OF STUDY- Randomized Controlled Trial STUDY AREA- Neonatal Intensive Care Unit, Neotia Getwel Multispeciality Hospital STUDY PERIOD – 1 Year STUDY POPULATION- all the neonates between 32 -36+6 weeks getting admitted in NICU between the study period INCLUSION CRITERIA - PMA: 320/7-36 6/7 weeks & PNA <14 days
- Requiring respiratory support (NPO2,NCPAP,HHHFNC,NIV) for >6 hours post birth.
EXCLUSION CRITERIA - Major congenital abnormality
- Renal or hepatic failure
- Arrythmias
- Babies requiring invasive MV within < 6 hrs
- Caffeine received previously within 48 hours
METHODOLOGY: Baby parents were counselled about the study and it’s purpose. Proper consent has to be taken. total number of patients will be divided (after all inclusion and exclusion criterias are met) into group ‘A’ and ‘B’. Group ’A’ will be given 20 mg/kg (as loading dose) caffeine citrate followed by 10mg/kg (as maintainance dose) till baby comes out of O2 support. Group’B’ will be given standard care and caffeine citrate to be considered only when they develop apnea of prematurity or baby requires invasive ventilation. Both group’A’ and group’B’ babies will be monitored on the basis of following parameters and will be followed up till 44 wks PMA 1.Intermittent hypoxia Episodes per 24 Hrs. 2.Duration Of Oxygen Support. 3.Any Complication Of Respiratory Support (Pneumothorax, Shock). 4.Side Effect Of Caffeine Therapy. 5.Feed Intolerance. 6.Interruption Of Feeding For 12 Hours. 7.Gestation Age For Discharge (Off Respiratory Support >48hrs, Gaining Weight Adequately, taking full feed by KS/ bottle, Mother Confident, No Major Morbidity). 8.Prevalance Of Re hospitalization before 44 Week Post Menstrual Age (PMA). |