Multisensory Early Oral Administration of Human Milk in Preterm Infants (M-MILK)

Loyola University

Status: Completed

Conditions: Infant Development; Stress

Treatments: Other: Multisensory Early Oral Administration of Human Milk (M-MILK)

Study type: Interventional

Funder types: Other

Identifiers

NCT06230848

217411

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• born between 22 to 34 weeks gestational age and receiving mother's own milk and/or donor milk.

Exclusion criteria

• receiving only formula, oral cavity defects, gastrointestinal defects, chromosomal abnormalities, severe cardiac defects that require surgery, or intraventricular hemorrhage grade III or IV

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Control

No Intervention group

Description:

Infants in the control group will receive standard of care.

M-MILK

Experimental group

Description:

Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care.

Treatment:

Other: Multisensory Early Oral Administration of Human Milk (M-MILK)