Effectiveness of Breast Milk Odor on Preterm Infant Feeding Cues: Protocol for a Randomized Clinical Trial

Preterm infants often experience physiological instability and immature feeding coordination, which can delay the transition to oral feeding and prolong hospitalization. Nonpharmacological interventions are increasingly used to support feeding readiness and neurobehavioral regulation. Exposure to breast milk odor has shown potential benefit. However, robust evidence from randomized controlled trials using validated outcome measures remains limited, particularly in the Indonesian context.

This study aims to evaluate the effectiveness of breast milk odor on feeding cues and time to first successful breastfeeding in preterm infants admitted to the neonatal intensive care unit (NICU).

This study is a single-blind randomized controlled trial currently underway with 2 parallel groups involving 96 preterm infants (gestational age 32-34 weeks) admitted to the NICU. Participants are randomly assigned to receive either breast milk odor exposure or a neutral odor control intervention. The intervention is administered 3 times daily for 3 consecutive days before feeding sessions. Feeding cues (the primary outcome) are assessed using the validated Feeding Cues Follow-Up Form (FCF-UF) during each feeding session (9 assessments over the 3-day intervention period). Time to first successful breastfeeding is assessed daily from day 4 until successful breastfeeding is achieved, or for a maximum follow-up of 10 days. Statistical analysis will be conducted after data collection is completed, with significance set at P<.05.

This study was funded in May 2025. Recruitment commenced in December 2025 and was completed in March 2026. A total of 104 participants were enrolled. Data collection was completed in April 2026, and data cleaning and statistical analysis were completed in August 2026. The study findings are expected to be published in 2026.

This trial will provide evidence on whether breast milk odor is an effective, low-cost intervention to improve feeding readiness and facilitate earlier breastfeeding initiation in preterm infants.