| CTRI Number |
CTRI/2019/05/019436 [Registered on: 30/05/2019] Trial Registered Prospectively |
| Last Modified On: |
26/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Stages of sensory registering abilities in preterm infants: A cross-sectional study |
|
Scientific Title of Study
|
Patterns of sensory processing abilities in preterm infants: A cross-sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ester Debora |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational therapy, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7259728075 |
| Fax |
|
| Email |
estherhelena08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KR Banumathe |
| Designation |
Assistant professor- Selection grade |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational therapy, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9035120310 |
| Fax |
|
| Email |
banumathe.kr@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ester Debora |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational therapy, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7259728075 |
| Fax |
|
| Email |
estherhelena08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal-576104, Karnataka |
|
|
Primary Sponsor
|
| Name |
Ester Debora |
| Address |
Department of occupational therapy, Manipal College of Health Professions, MAHE, Manipal |
| 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 |
| Ester Debora |
Kasturba hospital |
Neonatal intensive care unit,Kasturba hospital, Manipal
Udupi
KARNATAKA |
7259728075
estherhelena08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: F843||Other childhood disintegrative disorder, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Month(s) |
| Age To |
2.00 Month(s) |
| Gender |
Both |
| Details |
oInfants who
â–¡Born between 28 weeks to 37 weeks of gestation.
â–¡Both the genders
â–¡Are in between the age of one week to eight weeks.
oCaregiver who is in contact with the infant of four hours in NICU for minimum of two days.
|
|
| ExclusionCriteria |
| Details |
1.Infants with any History of congenital heart disease, reflux, visual impairment, auditory impairment, neonatal seizure and who have undergone any surgery as per the medical file.
2.Caregivers, Who have been diagnosed with mental illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The patterns of sensory processing abilities (such as low registration, sensation seeking, and
sensation avoiding and sensory sensitivity) would be identified in preterm infants. |
At the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The pattern of sensory processing abilities between genders, hospital stay and so on |
At the end of the study |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "76"
Final Enrollment numbers achieved (India)="76" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2019 |
| Date of Study Completion (India) |
29/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a cross- sectional study where a questionnaire would be provided to the caretakers of the pretrm infants to know their sensory abilities.The study would help in understanding the sensory processing patterns in preterm infants that would aid in using sensory integration therapy by occupational therapists working with preterm infants. It would also be helpful in planning for home programme when the infant gets discharged from the step- down unit. The results of this study may pave way to strengthen our role in NICU, especially in the Indian context. |