NCT06230848

Multisensory Early Oral Administration of Human Milk in Preterm Infants

Multisensory Early Oral Administration of Human Milk in Preterm Infants to Attenuate Early Life Toxic Stress on Epigenetic Modifications and Dysbiosis: Randomized Controlled Trial Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Loyola University · Academic / Other
• Sex: All
• Age: 0 Years – 1 Year
• Healthy volunteers: Not accepted

Summary

The aims of this pilot are to determine the feasibility and acceptability of the Multisensory early oral administration of human milk (M-MILK) intervention, recruitment, retention, and obtain data for sample size estimation. This study will advance nursing science and practice because it will inform our R01 RCT to examine the efficacy of M-MILK to attenuate adverse effects of early life toxic stress in preterm infants.

Conditions

• Infant Development
• Stress

Interventions

Type	Name	Description
OTHER	Multisensory Early Oral Administration of Human Milk (M-MILK)	M-MILK is implemented starting on day 3 of life, after every hands-on care, during the beginning of a full gavage feeding. Infants receive M-MILK in small droplets via a 1-ml syringe. M-MILK will cease upon oral feeding initiation. Infants will receive either mother's own milk or donor's milk based on availability. Infants may receive up to 1 mL of milk each time based on their cues and responses. The 1 mL volume intake is included as part of their oral caloric intake. M-MILK is provided by nurses or parents.

Timeline

• Start date: 2023-10-23
• Primary completion: 2024-10-23
• Completion: 2024-10-23
• First posted: 2024-01-30
• Last updated: 2026-01-08
• Results posted: 2026-01-08

Locations

1 site across 1 country: United States