| CTRI Number |
CTRI/2025/07/090985 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Tracking How Preterm Babies Develop Compared to Full-Term Babies – From When They’re Born to Their Expected Due Date. |
|
Scientific Title of Study
|
Contrasting the neuro developmental trajectories in moderate to late preterm infants at birth
and at term corrected age with their full term counterparts. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shehanaz samsudeen |
| Designation |
Post Graduate student |
| Affiliation |
Sri Ramakrishna institute of paramedical sciences. |
| Address |
4 th floor, Department of physiotherapy, Sri Ramakrishna institute of paramedical sciences. 395, Sarojini Naidu road, Siddhapudur, Coimbatore.
Coimbatore
TAMIL NADU
641044
India |
| Phone |
6384680242 |
| Fax |
|
| Email |
shehanazsamsudeen07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Senthil kumar |
| Designation |
assistant professor |
| Affiliation |
Sri Ramakrishna institute of paramedical sciences. |
| Address |
4th floor, Department of physiotherapy, Sri Ramakrishna institute of paramedical sciences. 395, Sarojini Naidu road, Siddhapudur, Coimbatore.
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9944182647 |
| Fax |
|
| Email |
asenthilpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shehanaz samsudeen |
| Designation |
Post Graduate student |
| Affiliation |
Sri Ramakrishna institute of paramedical sciences. |
| Address |
4th floor, Department of physiotherapy, Sri Ramakrishna institute of paramedical sciences. 395, Sarojini Naidu road, Siddhapudur, Coimbatore.
Coimbatore
TAMIL NADU
641044
India |
| Phone |
6384680242 |
| Fax |
|
| Email |
shehanazsamsudeen07@gmail.com |
|
|
Source of Monetary or Material Support
|
| NICU ward, Sri ramakrishna hospital |
|
|
Primary Sponsor
|
| Name |
Shehanaz samsudeen |
| Address |
Sri Ramakrishna institute of paramedical sciences, 395 Sarojini Naidu road, Siddhapudur, Coimbatore 641044 |
| Type of Sponsor |
Other [Myself] |
|
|
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 |
| Dr Senthil kumar |
Sri Ramakrishna hospital |
a block, 1st floor, Neonatal intensive care university,395, Sarojini Naidu road, Siddhapudur, Coimbatore.
Coimbatore
TAMIL NADU |
9944182647
asenthilpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI RAMAKRISHNA HOSPITAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F849||Pervasive developmental disorder,unspecified, (2) ICD-10 Condition: F849||Pervasive developmental disorder,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.10 Month(s) |
| Age To |
0.80 Month(s) |
| Gender |
Both |
| Details |
Gestational age:
GROUP 1- moderate to late preterm (32-37 weeks)
GROUP 2- full term infants (39-41 weeks)
Birth weight above 1200 g.
APGAR score above 7.
Parents willing to give consent. |
|
| ExclusionCriteria |
| Details |
Clinically unwell.
Neonatal infections.
Congenital abnormality.
Chromosomal anomalies.
Birth injuries.
Significant bilirubinemia
Intrauterine infection.
Inborn errors of metabolism.
Children born with: Birth asphyxia, Intracranial hemorrhage, Neonatal seizures, Neural tube defects, Brain malformations, Hypotonia, encephalopathy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hammersmith Neonatal Neurological Examination |
At birth and at term corrected age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
25/08/2025 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Preterm infants and full term infants will be purposefully selected from Sri
Ramakrishna Hospital ensuring they met the inclusion and exclusion criteria
Informed consents will be obtained from the parents after explaining about my research
study. Both PTI and FTI will be examined using HNNE scale within one week after
birth.
During the examination the newborns should be undressed and placed on a open bed or
cot in a room with warmer.The examination is done between two consecutive feeds to ensure the baby is calm and
comfortable.
Preterm infants will be reassessed when they reach their term corrected age. During a
follow-up or during vaccination. If not possible, home visits will be scheduled. All the
data’s will be recorded and statistically analyzed.
|