| CTRI Number |
CTRI/2025/07/090455 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Audio-visual and olfactory stimulation] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Production of milk in mothers delivering preterm neonates after audiovisual and olfactory stimulation |
|
Scientific Title of Study
|
Impact of audiovisual and olfactory stimulation on the amount of milk production in mothers with preterm delivery-multicentric open label randomized control trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
H A Venkatesh |
| Designation |
Consultant Neonatologist,Manipal Hospital |
| Affiliation |
Manipal hospitals |
| Address |
Department Of Neonatology Manipal Hospital 9TH Floor 98/2 Rustom Bagh HAL Airport Road BENGALURU
Department Of Neonatology Manipal Hospital 9TH Floor 98/2 Rustom Bagh HAL Airport Road BENGALURU
Bangalore
KARNATAKA
560017
India |
| Phone |
9980135300 |
| Fax |
|
| Email |
venkatveena46@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
H A Venkatesh |
| Designation |
Consultant Neonatologist,Manipal Hospital |
| Affiliation |
Manipal hospital |
| Address |
Department of Neonatology Manipal Hospital 9TH floor 98/2 Rustom Bagh HAL airport road BENGALURU
Department of Neonatology Manipal Hospital 9TH floor 98/2 Rustom Bagh HAL airport road BENGALURU
Bangalore
KARNATAKA
560017
India |
| Phone |
9980135300 |
| Fax |
|
| Email |
venkatveena46@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
H A Venkatesh |
| Designation |
Consultant Neonatologist,Manipal Hospital |
| Affiliation |
Manipal hospital |
| Address |
Department of Neonatology Manipal Hospital 9TH floor 98/2 Rustom Bagh HAL airport road BENGALURU
Department of Neonatology Manipal Hospital 9TH floor 98/2 Rustom Bagh HAL airport road BENGALURU
Bangalore
KARNATAKA
560017
India |
| Phone |
9980135300 |
| Fax |
|
| Email |
venkatveena46@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Hospital
98/2 Rustom Bagh HAL Airport Road Bengaluru
560017
Karnataka India |
|
|
Primary Sponsor
|
| Name |
H A VENKATESH |
| Address |
98,HAL,Old Airport road,Kodihalli,Bengaluru -560017 |
| Type of Sponsor |
Other [Principal investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr H A Venkatesh |
Manipal hospital |
Department of neonatology Manipal Hospital 9th Floor 98/2 Rustom Bagh HAL Airport Road Bengaluru
Bangalore
KARNATAKA |
9980135300
venkatveena46@gmail.com |
| Dr D V Venkatesh Murthy |
Rajarajeshwari Medical College and Hospital |
Department of Pediatrics, 202, Mysor Road, Kangeri Satellite Town, KMBIPURA
560074
Bangalore
KARNATAKA |
8884089198
venkateshmurthy99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ethics committee , manipal hospitals |
Approved |
| Ethics committee, Rajarajeshwari Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To enhance milk production in mothers with preterm delivery |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Audio-visual stimulation group, Audio-visual olfactory stimulation group, control group |
The participants will be assigned to 3 groups: (1) an audio-visual group (2) an audio-visual-olfactory group (3) a control group. The audio-visual and audio-visual and olfactory group will watch a video with images and sounds of babies breastfeeding and crying during the extraction of mothers milk. The duration of the video will be 10minutes until the baby calms down and will be displayed on high definition television screen.
The audio-visual olfactory group , in addition to watching the video, will also receive an olfactory stimulus consisting of inhaling the cotton swab rubbed on the newborn babys skin before giving bath for approximately 3minutes for 7 days. |
| Comparator Agent |
control group receiving no intervention |
Mothers delivering preterm neonates will be considered with no interventional modalities. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Postpartum mothers with premature infants born between 27-37weeks of gestation, who have not received galactagogues, who do not have comorbidity or health complications in the breast and who wish to participate in the study. |
|
| ExclusionCriteria |
| Details |
Candidates who do not give consent for the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effect of audio-visual and olfactory stimulation on the volume of milk production in mothers. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the amount of increased milk production because of different modalities of stimulation |
6 months |
| To compare the impact of maternal variables with multisensory stimulation on breast milk production. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
04/12/2025 |
| 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
|
The majority of mothers during their immediate postpartum period are unable to produce enough milk for their preterm babies due to various reasons. Most of the NICUs depend upon either the donor human milk or the formula milk for such babies. In developing countries, many of the parents are not in the affordable condition to get donor human milk either. The feeding intolerance including necrotizing enterocolitis is common with formula milk in addition to the cost behind. This underscores the importance of species-specific mothers’ milk. We decided to improve the preterm mothers’ milk production by video-based audio-visual and olfactory stimulation. |