| CTRI Number |
CTRI/2025/05/086769 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
09/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [tele-lactation support through mobile application] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Tele-Lactation Support on Breastfeeding and Infant Health in Mothers of Preterm Babies |
|
Scientific Title of Study
|
Effectiveness of Comprehensive Tele lactation Support Program on breastfeeding and infant health outcomes among mothers of preterm babies admitted in NICU at University Hospital Sharjah |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepthy Prabhakar |
| Designation |
Clinical Instructor/Part time PhD Scholar |
| Affiliation |
University Hospital, Sharjah |
| Address |
Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai, India.
University City, Sharjah, United Arab Emirates
Chennai
TAMIL NADU
600116
India |
| Phone |
0586816386 |
| Fax |
|
| Email |
deepthyprabhakar@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SRajeswari |
| Designation |
Professor and HOD of OBG Nursing |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Faculty of Nursing,
Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai, India.
Chennai
TAMIL NADU
600116
India |
| Phone |
9840030985 |
| Fax |
|
| Email |
rajeswari.s@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaqueline Maria Dias |
| Designation |
Associate Professor |
| Affiliation |
College of Health Sciences, University of Sharjah |
| Address |
Nursing Department,
Division/Room Number - M23A
College of Health Sciences, University of Sharjah
Sharjah Emirate.
United Arab Emirates
Not Applicable
N/A
27272
Other |
| Phone |
0501043994 |
| Fax |
|
| Email |
jdias@sharjah.ac.ae |
|
|
Source of Monetary or Material Support
|
| University Hospital, Sharjah(Infrastructural support), Sharjah, United Arab Emirates(UAE) . PO BOX- 72772. |
|
|
Primary Sponsor
|
| Name |
Deepthy Prabhakar |
| Address |
Clinical Instructor, University Hospital, Sharjah, United Arab Emirates |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
United Arab Emirates |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jaqueline Maria Dias |
University Hospital, Sharjah |
Department - Neonatal Intensive Care Unit. Division/Room Number - Ground Floor, University Hospital, Sharjah, United Arab Emirates.
|
0501043994
jdias@sharjah.ac.ae |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Ramachandra Institute of higher education and research |
Approved |
| Ministry of Health and Prevention Research Ethics Committee |
Approved |
| UniveristyHospitalSharjahEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postpartum mothers of preterm babies |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comprehensive Telelactation Support Program |
A multifaceted approach aimed at providing breastfeeding support to mothers of preterm babies through various telecommunication technologies.The programme includes educational resources, live chat facility and online consultation. Participants will have access to the mobile application from the time of enrollment until six months post-discharge from the NICU. |
| Comparator Agent |
Standard care for breastfeeding support, as per routine practice |
The control group will receive the usual standard of care provided in the NICU, which does not include any telelactation support. This could involve general breastfeeding guidance or face-to-face lactation support that is typically available at the facility, but no use of remote or online lactation services.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
- Mothers who have access to a smartphone with internet connectivity and to be able to use the app independently.
- Mothers who have given birth to preterm infants between 32 to less than 37 Weeks of gestation, who are admitted NICU.
- Mothers who are willing to participate in the telelactation intervention.
- Mothers who are able to communicate effectively in English or Arabic.
|
|
| ExclusionCriteria |
| Details |
- Mothers who are critically ill/admitted to ICU.
- Mothers with contraindications to breastfeeding or feeding expressed breast milk to infants.
- Mothers of preterm babies for whom breastmilk is contraindicated like metabolic disorders such as phenylketonuria, Galactosemia.
- Mothers who did not deliver their preterm infants at the designated study setting.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Exclusive breastfeeding rate |
At the time of discharge, 4th month and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Initiation of Breastfeeding
2. Type of Feeding.
3. Maternal knowledge about breastfeeding
4. Maternal breastfeeding self-efficacy
5. Breastfeeding difficulties or challenge
6. Length of NICU stay
7. Weight gain of the baby
8. Usability of the telelactation support system. |
At the time of discharge, 4th month and 6th month |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="0"
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)
|
01/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2025 |
| 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 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
|
This study aims to assess the effectiveness of a tele-lactation support program for preterm mothers, focusing on improving breastfeeding outcomes. Participants will be randomly assigned to either an experimental group, receiving tele-lactation support, or a control group, receiving standard care. The primary outcome is the exclusive breastfeeding rate. Secondary outcomes include the initiation of breastfeeding, type of feeding, maternal knowledge about breastfeeding, maternal breastfeeding self-efficacy, breastfeeding difficulties or challenges, length of NICU stay, weight gain of the baby, and the usability of the tele-lactation support system. The study will be conducted in the United Arab Emirates, where the author is a part-time PhD scholar at Sri Ramachandra Institute of Higher Education and Research while working in the UAE. |