| CTRI Number |
CTRI/2022/05/042379 [Registered on: 05/05/2022] Trial Registered Prospectively |
| Last Modified On: |
28/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To compare the outcomes of neonates who received surfactant for breathing difficulty with neonates who did not, in an advanced neonatal care unit in South India. |
|
Scientific Title of Study
|
Influence of surfactant administration on neonatal outcomes in a tertiary care neonatal unit in South India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC-AIMS-2021-ANES-182 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riya Asokan |
| Designation |
MSc Respiratory Therapy Trainee |
| Affiliation |
Amrita Institute Of Medical Sciences |
| Address |
Riya Asokan
MSc Respiratory Therapy
Division of Respiratory Therapy
6th tower 4th floor
(Ext Number 1701)
Department of Anesthesiology
Amrita Institute Of Medical Sciences
Kochi
Riya Asokan
MSc Respiratory Therapy
Division of Respiratory Therapy
Department of Anesthesiology
Amrita Institute Of Medical Sciences
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
8606446072 |
| Fax |
|
| Email |
riyaasok@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aswin S Prabhu |
| Designation |
Assistant Professor |
| Affiliation |
Department of neonatology , Amrita Institute Of Medical Sciences |
| Address |
Dr Aswin S Prabhu
Clinical Assistant Professor
4th tower 5th floor (Ext Number: 4579)
Department Of Neonatology
Amrita Institute Of Medical Sciences
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9847055806 |
| Fax |
|
| Email |
dr.ashwinsp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aswin S Prabhu |
| Designation |
Assistant Professor |
| Affiliation |
Amrita Institute Of Medical Sciences |
| Address |
Dr Aswin S Prabhu
Clinical Assistant Professor
4th tower 5th floor (Ext. Number 4579)
Department Of Neonatology
Amrita Institute Of Medical Sciences
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9847055806 |
| Fax |
|
| Email |
dr.ashwinsp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute Of Medical Science Kochi (Since It is an observational study no monetary or material support required.) |
|
|
Primary Sponsor
|
| Name |
Riya Asokan |
| Address |
MSc Respiratory Therapy
Department of Anesthesiology
Amrita Institute Of Medical Sciences
Kochi |
| 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 |
| Riya Asokan |
Neonatal Intensive Care Unit |
Neonatal Intensive Care Unit
Department Of Neonatology
4th Tower 5th Floor
Amrita Institute Of Medical Sciences
Kochi
Ernakulam
KERALA |
8606446072
riyaasok@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Of Amrita Institute Of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
All inborn neonates with respiratory distress born between 23-34 weeks.
|
|
| ExclusionCriteria |
| Details |
Newborns >34 weeks gestation at birth
All out born babies
Infants who received surfactant for indications other than RDS (Eg; Pulmonary hemorrhage, Meconium aspiration)
Infants with fatal congenital anomalies
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the mortality rate of preterm infants who received surfactant with infants who did not receive surfactant.
|
The outcomes will be assessed at the time of discharge / death. (However, all the date are collected retrospectively) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the following outcomes :
The major morbidities (ROP, BPD, IVH)
To evaluate the incidence of Type I RDS in preterm neonates less than 34 weeks.
The length of NICU stay
Duration of invasive / non-invasive ventilation
Impact of early versus late surfactant administration (less than 6 hrs and after 6hrs)
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
10/05/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This Study is a retrospective cross-sectional study to determine the influence of surfactant therapy in preterm neonates .Patients were divided into two groups: no surfactant and single (or) multiple doses. Decision to administer surfactant was based on established diagnostic criteria for RDS adapted to a resource limited setting. The primary outcome was a composite of mortality and any of the major morbidities, including IVH (grade 3 or 4), bronchopulmonary dysplasia or retinopathy of prematurity. |