Currently accepted at: JMIR Research Protocols
Date Submitted: Dec 15, 2025
Date Accepted: Jul 22, 2026
This paper has been accepted and is currently in production.
It will appear shortly on 10.2196/89618
The final accepted version (not copyedited yet) is in this tab.
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Effectiveness of Breast Milk Aroma on Preterm Infant Feeding Cues: A Randomized Clinical Trial Protocol
ABSTRACT
Background:
Olfactory stimulation using breast milk aroma is a viable non-pharmacological approach that has been shown to improve breastfeeding readiness and psychological stability in preterm infants. However, no randomised, double-blind clinical trials in Indonesia have evaluated the effectiveness of breast milk aroma using objective and validated instruments
Objective:
To evaluate the effectiveness of breast milk aroma on feeding cues and the timing of first oral feeding in premature infants admitted to the NICU
Methods:
This study employed a double-blind, randomised clinical trial design with two parallel groups, constituting 96 NICU-admitted premature infants with a gestational age of 32–34 weeks. The intervention group was exposed to breast milk aroma, while the control group received a placebo. Feeding cues were assessed using the Feeding Cues Follow-Up Form (PFC-UF), and the time to first oral feeding was measured with a stopwatch on the fourth day
Results:
This study is expected to generate data comparing feeding cue scores and the time to first oral feeding between the breast milk aroma group and the control group in preterm infants admitted to the NICU. The findings will provide preliminary evidence regarding the potential role of breast milk aroma as an olfactory intervention to support feeding readiness in premature infants.
Conclusions:
This study protocol describes a single-blind randomized clinical trial designed to evaluate the effectiveness of breast milk aroma on feeding cues and the timing of first oral feeding in preterm infants admitted to the NICU. The trial is expected to provide evidence on the potential role of olfactory stimulation as a non-pharmacological intervention to support feeding readiness and facilitate the transition to oral feeding in premature infants. If shown to be effective, breast milk aroma stimulation may represent a safe, low-cost, and feasible strategy for integration into routine NICU care Clinical Trial: INA-5RCW7NLO
Citation
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.