| CTRI Number |
CTRI/2009/091/000041 [Registered on: 03/02/2009] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
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A study to determine whether closure of Patent ductus arteriosus with indomethacin on the basis of size in the first 24 hrs of life in preterm babies between 28-32 weeks having respiratory difficulty is required or not. |
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Scientific Title of Study
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A Randomized Controlled Trial comparing Indomethacin vs. No treatment for PDA on the basis of Size in the first 24 hrs of life in Preterm babies between 28 to 32 weeks gestation requiring Assisted Ventilation |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Anil Batra |
| Designation |
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| Affiliation |
|
| Address |
Department of Neonatology
Sir Ganga Ram Hospital
New Delhi
DELHI
110060
India |
| Phone |
911142251153 |
| Fax |
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| Email |
drbatra77@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Satish saluja |
| Designation |
|
| Affiliation |
Sir Ganga Ram Hospital, New Delhi |
| Address |
Department of Neonatology
Sir Ganga Ram Hospital
New Delhi
DELHI
110060
India |
| Phone |
911142251738 |
| Fax |
|
| Email |
ssaluja@vsnl.com |
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Details of Contact Person
Public Query
|
| Name |
Satish saluja |
| Designation |
|
| Affiliation |
|
| Address |
Department of Neonatology
Sir Ganga Ram Hospital
New Delhi
DELHI
110060
India |
| Phone |
911142251738 |
| Fax |
|
| Email |
ssaluja@vsnl.com |
|
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Source of Monetary or Material Support
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Primary Sponsor
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| Name |
Anil Batra |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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| Name |
Address |
| Satish Saluja |
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anil Batra |
Department of Neonatology |
Department of Neonatology,Sir Ganga Ram Hospital-110060
New Delhi
DELHI |
911142251153
drbatra77@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sir Ganga Ram Hospital |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Patent Ductus Arteriosus in preterm babies requiring ventilation, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Indomethacin |
0.2mg/kg intravenously followed by 0.1 mg/kg 2 doses every 24 hrs |
| Comparator Agent |
No Treatment |
NIL |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
Preterm 28 - 32 weeks admitted to NICU within 12 hrs of birth
Ventilatory support for respiratory distress
PDA more than or equal to 2 mm in size in the first 24 hrs of life |
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| ExclusionCriteria |
| Details |
Babies with major congenital malformations
Any contraindication of giving indomethacin
Babies with severe asphyxia as defined by Apgar score, <3 at 5 min of life with cord/with in 1 hour of life pH< 7.0 or base excess >16
Shock requiring pressor support at time of randomization
Refusal to obtain consent
Gestation below 28 weeks
Presence of other cardiac malformations including ASD, VSD, any cause of left ventricular dysfunction and mitral valve abnormalities
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Closure of PDA at 7 days of life |
7 days |
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Secondary Outcome
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| Outcome |
TimePoints |
| Duration of assisted ventilation
Hemodynamically significant PDA at 3 days of age
Pulmonary hemorrhage
Intraventricular haemorrhage
Duration of oxygen dependence
Duration of hospital stay
Sepsis
Side effects related to indomethacin
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3 days
Nursery stay |
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Target Sample Size
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Total Sample Size="0"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 4 |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/03/2007 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years=""
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This study is a randomized controlled trial comparing indomethacin vs no treatment for PDA on the basis of size in first 24 hrs of life in preterm ventilated babies requiring ventilatory support. this study is being conducted in a tertiary level NICU of Sir Ganga Ram Hospital in New Delhi. the primary outcome measure will be PDA closure at 7 days of age. The secondary outcome measures will include Duration of assisted ventilation, Hemodynamically significant PDA at 3 days of age, Pulmonary hemorrhage,Intraventricular haemorrhage,
Duration of oxygen dependence, Duration of hospital stay,
Sepsis and the side effects related to indomethacin.
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