| CTRI Number |
CTRI/2010/091/006121 [Registered on: 17/01/2011] |
| 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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Music listening by mothers during pregnancy affects Newborn Behaviour |
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Scientific Title of Study
|
Maternal music exposure during pregnancy influences Neonatal Behaviour |
| 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 |
Ravindra Arya |
| Designation |
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| Affiliation |
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| Address |
SRA Pediatric Neurology, Dept of Pediatrics
AIIMS, Ansari Nagar
New Delhi
DELHI
110 029
India |
| Phone |
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| Fax |
|
| Email |
ravindra.arya4@gmail.com |
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Details of Contact Person
Scientific Query
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| Name |
Maya Chansoria |
| Designation |
|
| Affiliation |
Prof. & HOD Pediatrics, NSCB Medical College, Jabalpur, MP |
| Address |
Dept of Pediatrics
NSCB Medical college
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
07612422117 |
| Fax |
|
| Email |
maya.chansoria@yahoo.com |
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Details of Contact Person
Public Query
|
| Name |
Maya Chansoria |
| Designation |
|
| Affiliation |
|
| Address |
Dept of Pediatrics
NSCB Medical college
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
07612422117 |
| Fax |
|
| Email |
maya.chansoria@yahoo.com |
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Source of Monetary or Material Support
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| Department of Pediatrics, NSCB Medical College, Jabalpur, MP |
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Primary Sponsor
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| Name |
Department of Pediatrics, NSCB Medical College, Jabalpur, MP |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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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 |
| Dr. Maya Chansoria |
Department of Pediatrics, NSCB Medical College, Jabalpur, MP |
Department of Pediatrics, NSCB Medical College, Jabalpur, MP,-482003
Jabalpur
MADHYA PRADESH |
07612422117
maya.chansoria@yahoo.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, NSCB Medical College, Jabalpur, MP |
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 |
None (Normal healthy term newborns) , |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Music |
50 minutes/day |
| Comparator Agent |
Standard care |
Not applicable |
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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 |
* Primigravida mothers
* 19 to 29 years of age
* Singleton pregnancy
* Less than 20 weeks of gestation |
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| ExclusionCriteria |
| Details |
* Mothers with significant co-existing medical diseases
* Severe to profound hearing loss
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Method of Generating Random Sequence
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Random Number Table |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| performance on Brazelton Neonatal Behavioral Assessment Scale (BNBAS) |
Day 3 of life |
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Secondary Outcome
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| Outcome |
TimePoints |
| Nil |
Not applicable |
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Target Sample Size
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Total Sample Size="250"
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 3/ Phase 4 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/01/2003 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="3"
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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Objective:
Auditory stimulation during pregnancy has been found to influence foetal behaviour with a potential of being carried forward to neonatal period. This study evaluated the effect of ante-natal music exposure to primigravida healthy mothers on the behaviour of their term appropriate-for-date newborns assessed using Brazelton Neonatal Behavioral Assessment Scale (BNBAS).
Methods:
This was a single centre, randomized, open-label controlled trial. Primigravida mothers aged 19-29 years, free of chronic medical diseases or significant deafness, with singleton pregnancy, with a gestation of 20 weeks or less were randomized to listen to a pre-recorded music cassette for approximately 1 hour/day in addition to standard ante-natal care (intervention arm) or standard care only (control arm). Peri-natal factors with adverse effect on neonatal behaviour were deemed as protocol violations. Outcome measure included scores on 7 clusters of BNBAS. Primary analysis was per protocol.
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