Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants (M-MILK RCT)

Loyola University

Status: Enrolling

Conditions: Infant, Premature, Diseases

Treatments: Other: Multisensory early oral administration of human milk

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07216664

218601

Details and patient eligibility

About

The goal of this clinical trial is to learn if the multisensory early oral administration of human milk (M-MILK) intervention helps infants who are born younger than 32 weeks gestational age (very preterm infants). The main question that this clinical trial aims to answer is: Does M-MILK improve stress regulation, support optimal neurodevelopment, and promote competent oral feeding skills in very preterm infants?

Researchers will compare M-MILK to the standard of care to see if M-MILK helps very preterm infants. Specifically, researchers will compare the differences in:

• Cortisol levels
• DNA methylation of the two stress related genes (NR3C1 and HSD11B2)
• Neurodevelopment
• Oral feeding skills Participants in the M-MILK group will receive standard of care plus M-MILK intervention, which starts on day 3 of life and continues until they begin their oral feeding. M-MILK will be provided by clinical research nurses, during the day shift, up to 4 times a day. Participants in the standard of care group will continue to receive their usual care.

Enrollment: 125 estimated patients

Sex: All

Ages: 23 to 32 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Born at ≤ 32 weeks gestational age.
• Receiving mother's own milk and/or donor human milk at the time of screening.

Exclusion criteria

• Receiving only formula.
• Gastrointestinal defects, i.e., cleft lip or cleft palate.
• Congenital cardiac defects requiring surgery.
• Necrotizing enterocolitis.
• Chromosomal abnormalities.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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125 participants in 2 patient groups

M-MILK Group

Experimental group

Description:

Infants in the M-MILK group will receive M-MILK intervention and standard of care. M-MILK is implemented starting on day 3 of life, during the day shift, after every hands-on care, during the beginning of a full gavage feeding, and up to 4 times a day. 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 research nurses or parents.

Treatment:

Other: Multisensory early oral administration of human milk

Control Group

No Intervention group

Description:

Infants in the Control group will receive standard of care.