| CTRI Number |
CTRI/2018/07/014793 [Registered on: 10/07/2018] Trial Registered Prospectively |
| Last Modified On: |
09/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess abnormal thinking and behavioral patterns using package among very low birth weight,early born children. |
|
Scientific Title of Study
|
A Randomized Controlled Trial to evaluate the effectiveness of "Cognitive Behavior Assessment and Intervention Package" on cognitive functioning and behavioral psychopathology among very low birth weight preterm children at Pediatric OPD,PGIMER, Chandigarh in 2017-19. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruchi Saka |
| Designation |
Masters of Nursing Student |
| Affiliation |
Post graduate Institute of Medical Education and Research Chandigarh - 160012. |
| Address |
Room No. 208, National Institute of Nursing Education, PGIMER, Chandigarh - 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09569145327 |
| Fax |
|
| Email |
sakaruchi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanya Mukhopadhyay |
| Designation |
Associate Professor (Neonatology) Department of Paediatrics |
| Affiliation |
Post graduate Institute of Medical Education and Research Chandigarh - 160012. |
| Address |
Neonatal Unit,Department of Paediatrics, Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh,India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09914208317 |
| Fax |
|
| Email |
kanya.pgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ruchi Saka |
| Designation |
Masters of Nursing Student |
| Affiliation |
Post graduate Institute of Medical Education and Research Chandigarh - 160012. |
| Address |
Room No. 208, National Institute of Nursing Education, Sector 12, PGIMER, Chandigarh - 160012, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09569145327 |
| Fax |
|
| Email |
sakaruchi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ruchi Saka, Room No. 128, A-Block, Nibedita Hostel, Sector 12, PGIMER, Chandigarh. PIN 160012.
Phone 09569145327
E-mail sakaruchi@gmail.com |
|
|
Primary Sponsor
|
| Name |
Ruchi Saka |
| Address |
Room No. 208, National Institute of Nursing Education, PGIMER, Chandigarh - 160012. |
| 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 |
| Ruchi Saka |
Postgraduate Institute of Medical Education and Research, Chandigarhchandigarh |
Room no. 2014,Child Psychology Clinic, Paediatric OPD, Advance Paediatric Centre, PGIMER, Chandigarh-160012.
Chandigarh
CHANDIGARH |
9569145327
sakaruchi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Postgraduate Institute of Medical Education and Research, Chandigarh. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Low Birth Weight Preterm Children with Cognitive and behavioral dysfunctions., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitive Behavior Assessment and Intervention Package. |
Cognitive Behavior Assessment and Intervention Package in terms of Child Interventional activities and Parental Education.
Duration of Package: 4 months. |
| Comparator Agent |
Routine Care |
Routine Information
Duration: 4 months. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Very Low Birth Weight Preterm Children (age group 4 to 8 years) attending Paediatric OPD, Advance Paediatric Centre, PGIMER, Chandigarh. |
|
| ExclusionCriteria |
| Details |
Low Birth Weight Preterm Children with cerebral injuries, neurosensory disabilities, genetic abnormalities and/or developmental quotient below normal limits (<1 SD) at 6 years. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improved Cognitive functioning and behavioral psychopathology among Very Low Birth Weight Preterm Children. |
4 months
(After the implementation of Cognitive Behavior Assessment and Intervention Package on Experiment group) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved Social competence, cognitive and behavior functioning among Very Low Birth Weight Preterm Children. |
After three months of Post Intervention Package. |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/07/2018 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
"None Yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
A Randomized Controlled Trial to evaluate the effectiveness of "Cognitive Behavior Assessment and Intervention Package" on cognitive functioning and behavioral psychopathology among Very Low Birth Weight Preterm Children at Paediatric OPD, PGIMER, Chandigarh in 2017- 19. This is a postgraduate thesis of assessment and intervention among Very Low Birth Weight Preterm Children presented with cognitive and behavioral dysfunctions through "Cognitive Behavior Assessment and Intervention Package" which includes Child Intervention Activities and Parental Education.
|