| CTRI Number |
CTRI/2022/09/045520 [Registered on: 14/09/2022] Trial Registered Prospectively |
| Last Modified On: |
11/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of developmental delay in term babies who are on breathing support: Retrospective observational study. |
|
Scientific Title of Study
|
Evaluation of developmental delay in term babies who are on ventilator support: Retrospective observational study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hemanth Kumar R |
| Designation |
Post Graduate Student |
| Affiliation |
Nitte Institute of Physiotherapy Nitte Deemed to be University |
| Address |
Nitte Institute of Physiotherapy Nitte Deemed to be University,
Nithyanandha Nagar Deralakatte Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9042672221 |
| Fax |
|
| Email |
rhk3027@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayesh Chandran |
| Designation |
Assistant professor |
| Affiliation |
Nitte Institute of Physiotherapy Nitte Deemed to be University |
| Address |
Nitte Institute of Physiotherapy Nitte Deemed to be University,
Nithyanandha Nagar Deralakatte Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9383443710 |
| Fax |
|
| Email |
jayeshnairpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hemanth Kumar R |
| Designation |
Post Graduate Student |
| Affiliation |
Nitte Institute of Physiotherapy Nitte Deemed to be University |
| Address |
Nitte Institute of Physiotherapy Nitte Deemed to be University,
Nithyanandha Nagar Deralakatte Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9042672221 |
| Fax |
|
| Email |
rhk3027@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nitte institute of physiotherapy |
|
|
Primary Sponsor
|
| Name |
Nitte institute of physiotherapy |
| Address |
Nitte Institute of Physiotherapy Nitte Deemed to a University
Nityananda nagar deralakatte Mangalore
Karnataka 575018 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Hemanth kumar R |
Department of physiotherapy, KS Hedge charitable hospital |
Nitte institute of physiotherapy Deemed to be University
Nityananda nagar deralakatte Mangalore
Dakshina Kannada
KARNATAKA |
9042662221
rhk3027@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Nitte Institution of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Month(s) |
| Age To |
18.00 Month(s) |
| Gender |
Both |
| Details |
Low-risk babies who were full-term and underwent ventilator support in NICU.
Babies between 17 months to 18 months.
Babies who are spent more than 48 hours in ventilator support.
Parents who are well versed in English.
|
|
| ExclusionCriteria |
| Details |
All pre-term babies.
Babies with spinal and brain anomalies.
Genetic disorders.
Babies with Peripheral nerve injuries and congenital anomalies.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ages and Stages Questionnaire – 3 |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/09/2022 |
| 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="11"
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)?
Response - NO
|
|
Brief Summary
|
The retrieved literatures have proved that the preterm babies and underweight babies who remains in NICU are more inclined to developmental delay. Though there are some studies done on the effect of invasive ventilators such tracheostomy in a preterm baby that leads to developmental delay, no studies have been done on how ventilator support affects critically ill full term babies. Due to this paucity of literature, this study has been taken to show how ventilator support will affect early moter development in critically ill full term babies |