N/A
Completed N=14
Multisensory Early Oral Administration of Human Milk in Preterm Infants
Infant Development · Stress
Source: ClinicalTrials.gov NCT06230848 ↗
Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcomePrimary: Feasibility of Intervention — 0; 7 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Intervention |
0; 7 | — |
| PRIMARY Acceptability of Intervention |
0; 5 | — |
| PRIMARY Retention |
4; 7 | — |
| PRIMARY The Scarf Sign Cluster of the Neurobehavioral Assessment of the Preterm Infants Score |
66.7; 66.7 | — |
| PRIMARY Variability in the Motor Development & Vigor Cluster of the Neurobehavioral Assessment of the Preterm Infants Score |
53.1; 60.9 | — |
| PRIMARY Popliteal Angle Cluster of the Neurobehavioral Assessment of the Preterm Infants Score |
16.7; 66.7 | — |
| PRIMARY Alertness and Orientation Cluster of the Neurobehavioral Assessment of the Preterm Infants Score |
41.3; 82.5 | — |
| PRIMARY Irritability Cluster of the Neurobehavioral Assessment of the Preterm Infants Score |
33.4; 33.4 | — |
| PRIMARY Quality of Cry Cluster of the Neurobehavioral Assessment of the Preterm Infants Score |
0; 25 | — |
| PRIMARY Percent Sleep Cluster of the Neurobehavioral Assessment of the Preterm Infants Score |
14.3; 14.3 | — |
| PRIMARY Early Feeding Skill Assessment Score |
47.3; 49.6 | — |
| SECONDARY Parent Stressor Scale: NICU Score |
2.4; 2.3 | — |
| SECONDARY Parent Discharge Readiness Score |
231.0; 211.0 | — |
| SECONDARY Breastmilk Pumping Rate |
1; 5 | — |
| SECONDARY Breastfeeding Rate |
0; 1 | — |
| SECONDARY Maternal Edinburgh Postnatal Depression Scale Score |
3.8; 4.8 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06230848). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.