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Recruiting NCT07216664

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

No phase Interventional Infant, Premature, Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multisensory early oral administration of human milk.
Who it may be relevant to
Registry conditions: Infant, Premature, Diseases. Basic parameters: 23 Weeks — 32 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Randomized Controlled Trial of Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants: Enhancing Stress Regulation, Neurodevelopment, and Oral Feeding Skills

Overview

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.

Interventions

  • Other Multisensory early oral administration of human milk
    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

Primary outcome measures

  • Oral feeding Skills: EFS assessment total score at PO Initiation [Time frame: Up to 12 weeks after birth.]
  • Oral Feeding Skills: EFS assessment total score at 36 Weeks PMA [Time frame: 36 weeks postmenstrual age.]
Secondary outcome measures (12)
  • Stress Regulation: Salivary Cortisol at PO Initiation [Time frame: Up to 12 weeks after birth.]
  • Stress Regulation: Salivary Cortisol at 36 Weeks PMA [Time frame: At 36 weeks postmenstrual age.]
  • Stress Regulation: Buccal Cell DNAm of NR3C1 Exon 1F Promoter at PO Initiation [Time frame: Up to 12 weeks after birth.]
  • Stress Regulation: Buccal Cell DNAm of NR3C1 Exon 1F Promoter at 36 Weeks PMA [Time frame: At 36 weeks postmenstrual age.]
  • Stress Regulation: Buccal Cell DNAm of HSD11B2 Promoter at PO Initiation [Time frame: Up to 12 weeks after birth.]
  • Stress Regulation: Buccal Cell DNAm of HSD11B2 Promoter at 36 Weeks PMA [Time frame: At 36 weeks postmenstrual age.]
  • Neurodevelopment: NNNS-II Attention score 36 Weeks PMA [Time frame: At 36 weeks postmenstrual age.]
  • Neurodevelopment: NNNS-II Handling score 36 Weeks PMA [Time frame: At 36 weeks postmenstrual age.]
  • Neurodevelopment: NNNS-II Self-Regulation 36 Weeks PMA [Time frame: At 36 weeks postmenstrual age.]
  • Neurodevelopment: NNNS-II Habituation score 36 Weeks PMA [Time frame: At 36 weeks postmenstrual age.]
  • Neurodevelopment: NNNS-II Arousal score 36 Weeks PMA [Time frame: At 36 weeks postmenstrual age.]
  • Neurodevelopment: NNNS-II Excitability score 36 Weeks PMA [Time frame: At 36 weeks postmenstrual age.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 2 centers
  • Loyola University Chicago — Maywood
  • Loyola University Medical Center — Maywood

Publications

  • Griffith T, Janusek L, White-Traut R, Green SJ, Sachin A, Joyce C. Study Protocol for a Randomized Controlled Trial of Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants: Enhancing Stress Regulation, Neurodevelopment, and Oral Feeding Skills. Biol Res Nurs. 2026 Jul;28(3):464-478. doi: 10.1177/10998004261418708. Epub 2026 Jan 19. PMID 41554032

Identifiers

NCT: NCT07216664 · 218601

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗