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Clinical Trials/CTRI/2025/07/090455
CTRI/2025/07/090455
Not yet recruiting
Phase 3

Impact of audiovisual and olfactory stimulation on the amount of milk production in mothers with preterm delivery-multicentric open label randomized control trial

H A VENKATESH2 sites in 1 country44 target enrollmentStarted: December 4, 2025Last updated:

Overview

Phase
Phase 3
Status
Not yet recruiting
Sponsor
H A VENKATESH
Enrollment
44
Locations
2
Primary Endpoint
To determine the effect of audio-visual and olfactory stimulation on the volume of milk production in mothers.

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
20.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Candidates who do not give consent for the study.

Outcomes

Primary Outcomes

To determine the effect of audio-visual and olfactory stimulation on the volume of milk production in mothers.

Time Frame: 6 months

Secondary Outcomes

  • 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)

Investigators

Sponsor
H A VENKATESH
Sponsor Class
Other [Principal investigator]
Responsible Party
Principal Investigator
Principal Investigator

H A Venkatesh

Manipal hospitals

Study Sites (2)

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