| CTRI Number |
CTRI/2023/03/050610 [Registered on: 13/03/2023] Trial Registered Prospectively |
| Last Modified On: |
12/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess of ability of mothers to conduct essential newborn care of moderate to late preterm neonates admitted in nicu |
|
Scientific Title of Study
|
Assessment of ability of mothers to conduct essential newborn care of moderate to late preterm neonates admitted in nicu: an intervention study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC KMC MLR 07/2022/280 , 20/07/2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Apeksha Gupta |
| Designation |
paediatrics junior resident |
| Affiliation |
kasturba medical college mangalore |
| Address |
kasturba medical college, lighthouse hill road, mangalore-575001, karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9108098850 |
| Fax |
|
| Email |
apeksha0612@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sowmini kamath |
| Designation |
associate professor, department of pediatrics |
| Affiliation |
kasturba medical college mangalore |
| Address |
kasturba medical college, lighthouse hill road, mangalore-575001, karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
|
| Fax |
|
| Email |
sowmini.kamath@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Apeksha Gupta |
| Designation |
paediatrics junior resident |
| Affiliation |
kasturba medical college mangalore |
| Address |
kasturba medical college, lighthouse hill road, mangalore-575001, karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9108098850 |
| Fax |
|
| Email |
apeksha0612@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government lady goschen hospital, maidan road, hampankatta, mangalore-575001, karnataka |
|
|
Primary Sponsor
|
| Name |
Apeksha Gupta |
| Address |
Kasturba Medical College, Lighthouse hill road, Mangalore, Karnataka- 575001 |
| 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 |
| Apeksha Gupta |
Government Lady Goschen Hospital |
Nicu, 3rd floor, maidan road, Hampankatta, Mangalore-575001, Karnataka
Dakshina Kannada
KARNATAKA |
9108098850
apeksha0612@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Mangalore |
Approved |
| noc from lady goschen hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
standard of care |
ongoing information education communication (iec) provided by government of karnataka and maturation improvement |
| Intervention |
video based intervention |
a video based educational tool describing the essential newborn care components in the local language, will be shown to the mothers having 10 videos of maximum duration of 2 minutes and improvement in the scores will be marked on those 10 checklists |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) mothers of Moderate to late preterm neonates admitted in NICU who are haemodynamically
stable (not on ionotropes), not on ventilator support (invasive or noninvasive).
2) The mothers who are willing and will be available to provide care to the infant.
3) Mothers of babies on expressed breast feed
4) Mothers of babies admitted for minimum duration of 7 days |
|
| ExclusionCriteria |
| Details |
1) Mothers of Neonates who are not hemodynamically stable (on ionotropes) and neonates requiring
ventilator support (invasive or noninvasive)
2)mothers of Neonates with congenital anomalies like Congenital heart diseases, cleft lip, cleft
palate, etc
3) Mothers of Neonates on Direct breast feeds
4) Mothers of Neonates admitted for <7 days
5) Mothers who cannot read and understand kannada language |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in maternal ability scores of conducting essential newborn care of premature
neonates pre and post intervention |
baseline knowledge via checklist will be assessed within 24 hours of admission and reassessed post video based intervention at day 7 of admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="190"
Sample Size from India="190"
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)
|
15/03/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The first few weeks of an infant’s life is an important time for the formation of healthy attachment between newborn and mother.
Integrating mothers in a newborn’s care during hospitalisation can maintain newborn- parent unity, promote supportive developmental care, and facilitate stable newborn and parent attachment.
There are not enough studies on maternal education in conducting essential newborn care in NICU and in Dakshina Kannada. Therefore in this study I would like to implement video based education and assess the effect of such intervention on maternal Essential newborn care skills on preterm babies . |