| CTRI Number |
CTRI/2024/11/076628 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Early intervention in NICU] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing a supportive care training package for small and sick newborns to see how practical and effective it is for use in special newborn care units (SNCUs). |
|
Scientific Title of Study
|
A Nurturing Care training package for
small and sick newborns,piloting and testing acceptability and
feasibility of this package for implementation in SNCUs |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arti Maria |
| Designation |
Director Professor, Department Of Neonatology |
| Affiliation |
Department of Neonatology ABVIMS and Dr RML Hospital New Delhi |
| Address |
A.B.V.I.M.S and Dr. Ram Manohar Lohia Hospital New Delhi
Central
DELHI
110001
India |
| Phone |
09818618586 |
| Fax |
|
| Email |
drartimaria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arti Maria |
| Designation |
Director Professor, Department Of Neonatology |
| Affiliation |
Department of Neonatology ABVIMS and Dr RML Hospital New Delhi |
| Address |
A.B.V.I.M.S and Dr. Ram Manohar Lohia Hospital New Delhi
Central
DELHI
110001
India |
| Phone |
09818618586 |
| Fax |
|
| Email |
drartimaria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arti Maria |
| Designation |
Director Professor, Department Of Neonatology |
| Affiliation |
Department of Neonatology ABVIMS and Dr RML Hospital New Delhi |
| Address |
A.B.V.I.M.S and Dr. Ram Manohar Lohia Hospital New Delhi
Central
DELHI
110001
India |
| Phone |
09818618586 |
| Fax |
|
| Email |
drartimaria@gmail.com |
|
|
Source of Monetary or Material Support
|
| WHO country office, World Health House, Indraprastha Estate, Mahatma Gandhi Marg, New Delhi 110 002, India.
|
|
|
Primary Sponsor
|
| Name |
World Health Organisation |
| Address |
World Health House, Indraprastha Estate, Mahatma Gandhi Marg, New Delhi 110002, India. |
| Type of Sponsor |
Other [United Nations Agency] |
|
|
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 Arti Maria |
Ram Manohar Lohia Hospital |
Department of neonatology. Baba Kharak Singh Marg,
Near Gurudwara Bangla Sahib,
Connaught Place, New Delhi, Delhi 110001
Central
DELHI |
09818618586
drartimaria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE ABVIMS AND DR. RAM MANOHAR LOHIA HOSPITAL NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Health care Providers in NICU |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Nurturing care training package for small and sick newborns |
A nurturing care training package designed specifically for small and sick newborns in SNCU settings. The training package builds on seven existing videos focused on early intervention and nurturing care and integrates these with a comprehensive training manual including 7 modules: 1.Sensitization regarding the nurturing care framework and early intervention
2.Optimizing health and nutrition
3.Responsive care giving by understanding infant cues
4.Providing a safe and secure environment, including:
a.Safeguarding sleep and clustering of care
b.Proper positioning and handling
c.Pain management and skin protection
5.Opportunities for early learning for optimal early childhood development
. The project emphasizes family-centered care to engage and empower caregivers, equipping them with skills to support their newborns’ developmental needs. Duration of intervention - 9 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Healthcare providers who are posted in NICU |
|
| ExclusionCriteria |
| Details |
Health care providers not willing to participate in the training |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To train all the healthcare professionals on nurturing care practices posted in the NICU. |
Baseline assessment - before first training session of healthcare professionals in NICU. Endline assessment - after completion of implementation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved quality of care & developmental support for high-risk newborns |
Baseline assessment- before the 1st training
Midline assessment - after 3 month of implementation
Endline assessment - after completion of implementation |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/12/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This project aims to develop, pilot, and evaluate a nurturing care training package tailored for small and sick newborns within Special Newborn Care Units (SNCUs) in India. Led by ABVIMS & RML Hospital, New Delhi, the project builds on seven audiovisual modules aligned with the WHO Nurturing Care Framework, focusing on essential areas such as optimizing health and nutrition, responsive caregiving, safeguarding sleep, proper handling, pain management, and early learning opportunities. Emphasizing family-centered care, the package actively involves caregivers, empowering them as partners in their newborns’ development. Initially, the training package will be implemented in RML Hospital’s NICU, followed by three additional SNCU sites. Swami Dayanand Hospital, New Delhi, Sawai Man Singh Medical College and Hospital, Jaipur and SDH Yagya Narayan Hospital, Kishangarh. The study will gather both qualitative and quantitative data to assess feasibility and acceptability, ensuring that the package can be integrated into routine neonatal care in diverse settings. Expected outcomes include a replicable, scalable model of nurturing care that enhances quality of care, supports developmental outcomes for high-risk newborns, and fosters family engagement within SNCUs. |