| CTRI Number |
CTRI/2022/05/042476 [Registered on: 12/05/2022] Trial Registered Prospectively |
| Last Modified On: |
11/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Other (Specify) [Video assisted teaching, application of ear muffs, positioning the neonate] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Preparing mothers for supportive care at home to the babies born too early |
|
Scientific Title of Study
|
Effectiveness of Selected Interventions on Developmentally Supportive
Care and Quality Improvement among Mothers and Preterm Neonates at Nilofer hospital, Telangana |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
CHAKRAVARTULA ROJA RANI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Government College of Nursing
Santi Nagar
Karimnagar bypass road
Rajanna Sircilla
Institute of Mental Health
Erragadda
Hyderabad
500038
Hyderabad
TELANGANA
505301
India |
| Phone |
9490098689 |
| Fax |
|
| Email |
rojaranichakravartula@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Alimelu |
| Designation |
Professor and HOD |
| Affiliation |
Government of Telangana |
| Address |
Department of Neonatology
Nilofer hospital
Red hills
Hyderabad
Same
Hyderabad
TELANGANA
500004
India |
| Phone |
9391319672 |
| Fax |
|
| Email |
asvnrao@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
M Padmasri |
| Designation |
Special Associate |
| Affiliation |
State Bank of India |
| Address |
RACPC
State Bank of India
Krishna complex
Kalasiguda
Secunderabad
Same
Hyderabad
TELANGANA
500003
India |
| Phone |
9490098687 |
| Fax |
|
| Email |
padmamudunuru@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nilofer Hospital |
| Address |
Red Hills
Hyderabad
Telangana |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nilofer hospital |
Red Hills
Hyderabad
Telangana |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAlimelu |
Nilofer Hopital for women and children |
Department of Neonatology
Red Hills
Hyderabad
Hyderabad
TELANGANA |
9391319672
asvnrao@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Osmania Medical College |
Approved |
| Institutional Ethics Committee SRIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mothers of Preterm Neonates and Preterm neonates |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Animated Video for informing, involving, teaching by discussion, demonstrating supportive activities to prepare the mothers of preterm neonates before discharge
Application of ear muffs to the preterm neonates
Placing the preterm neonates in left lateral position |
- Video assisted guided participation discharge program by informing, involving, teaching by discussion, demonstrating supportive activities to prepare the mothers of preterm neonates before discharge, by the Nurse through Video, prepared by the investigator
- Application of ear muffs to the preterm neonates to analyze the physiological and behavioral response to noise
- Placing the preterm neonates in left lateral position after the feed to analyze the feeding tolerance
|
| Comparator Agent |
Routine Care |
Routine Care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
42.00 Year(s) |
| Gender |
Both |
| Details |
Mothers and preterm neonates
Preterm neonates who are born between 32 weeks to 36 weeks of gestation and their Mothers
Preterm neonates whose birth weight will be between 2000 grams to 2500 grams and their Mothers
Preterm neonates who will be admitted in level I & II NICU at Nioufer Hospital and their Mothers
Preterm neonates who will be available for one week before the discharge and their Mothers
Preterm neonates who will be inborn and outborn
Mothers who will have access to smart phone with internet facility
Mothers of preterm neonates who will be able to read and/or write in telugu and or urdu
|
|
| ExclusionCriteria |
| Details |
Mothers of preterm neonates with congenital anomalies
Mothers of preterm neonates who will be admitted from the places other than Telangana
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improving the awareness among mothers on care of preterm neonate after discharge
Growth and development of the preterm neonate |
Assessment of mothers knowledge and practices on 1&2 day after recruitment
Presentation of video to mothers on 1&2nd day after recruitment
Testing the mothers knowledge and practices after 48 hrs of video presentation
Assess selected parameters of Growth and development of the preterm neonate on day 1-5 after recruitment during hospitalization,two weeks and four weeks after discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Normal Growth and Development of preterm neonates |
Assessment of growth and development parameters of the preterm neonate during hospitalization and two weeks & four weeks after discharge |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
12/05/2022 |
| 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
|
India is having highest number of preterm births in the
world. As per Sample Registration Survey- 2016 -2017, IMR in India is
34/1000 live births and Neonatal Mortality rate is 24/1000 live births, which
indicates the alarming situation. Telangana recorded 29/1000. Government of
India is pouring funds in planning, organizing, staffing to some extent,
training, allocating resources in view of attaining SDGs related to maternal
and child health to improve the indicators by reducing infant mortality rate
and neonatal mortality rate, but the targets are far behind as per National
health Policy-2017
This project will be very
significant in bringing the quality improvement in the health of preterm
babies. The mothers and the family , who are seeking health services for their
preterm, especially in the Government health institutions, are in need of
education and training for taking care of the preterm at home after discharge.
Due to the Nurse - Patient ratio issues, one to one teaching is a challenge.
The education material prepared in the form of video for mothers and low cost
measures like ear plugs to reduce the noise levels in the immediate
surroundings of the preterm for a healing environment and keeping the
preterm in left lateral position after feeding to tolerate the feeds are
studied in this project. These interventions are useful to the family in
providing effective supportive care at home, fill certain human resources gaps among stakeholders and will also have impact on
reducing the neonatal mortality and morbidity
|