Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants
ConditionInfant, Premature, Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age23-32
SponsorLoyola University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Born at ≤ 32 weeks gestational age.
Receiving mother's own milk and/or donor human milk at the time of screening.
Disqualifiers
Receiving only formula.
Gastrointestinal defects, i.e., cleft lip or cleft palate.
Congenital cardiac defects requiring surgery.
Necrotizing enterocolitis.
Trial design
Design model
Parallel
Treatments tested in this trial
Multisensory early oral administration of human milk
Other interventionM-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 groups
125 Participants
are divided into 2 treatment groupsGroup A: M-MILK GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Oral feeding Skills: EFS assessment total score at PO Initiation
We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at oral feeding (PO) initiation. The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.
Time frame
Up to 12 weeks after birth.2
Oral Feeding Skills: EFS assessment total score at 36 Weeks PMA
We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at 36 weeks post-menstrual age (PMA). The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.
Time frame
36 weeks postmenstrual age.Secondary outcomes
1
Stress Regulation: Salivary Cortisol at PO Initiation
We will evaluate stress regulation, measured by salivary cortisol levels (μg/dL) at oral feeding (PO) initiation.
Time frame
Up to 12 weeks after birth.2
Stress Regulation: Salivary Cortisol at 36 Weeks PMA
We will evaluate stress regulation, measured by salivary cortisol levels (μg/dL) at 36 weeks PMA.
Time frame
At 36 weeks postmenstrual age.3
Stress Regulation: Buccal Cell DNAm of NR3C1 Exon 1F Promoter at PO Initiation
We will evaluate stress regulation, measured by buccal cell DNA methylation (DNAm) of NR3C1 Exon 1F promoter at oral feeding (PO) initiation. We anticipate to cover 33 CpG sites within the NR3C1 Exon 1F promoter. Methylation percentage (%) will calculated per CpG site (aligning with the human reference genome hg38).
Time frame
Up to 12 weeks after birth.4
Stress Regulation: Buccal Cell DNAm of NR3C1 Exon 1F Promoter at 36 Weeks PMA
We will evaluate stress regulation, measured by buccal cell DNA methylation (DNAm) of NR3C1 Exon 1F promoter at 36 weeks post-menstrual age (PMA). We anticipate to cover 33 CpG sites within the NR3C1 Exon 1F promoter. Methylation percentage (%) will calculated per CpG site (aligning with the human reference genome hg38).
Time frame
At 36 weeks postmenstrual age.Other outcomes
1
Oral Feeding Skills: EFS assessment score for Respiratory Regulation at PO Initiation
We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at oral feeding (PO) initiation. The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.
Time frame
Up to 12 weeks after birth.2
Oral Feeding Skills: EFS assessment score for Oral-motor Functioning at PO Initiation
We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at oral feeding (PO) initiation. The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.
Time frame
Up to 12 weeks after birth.3
Oral Feeding Skills: EFS assessment score for Swallowing Coordination at PO Initiation
We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at oral feeding (PO) initiation. The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.
Time frame
Up to 12 weeks after birth.4
Oral Feeding Skills: EFS assessment score for Engagement at PO Initiation
We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at oral feeding (PO) initiation. The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.
Time frame
Up to 12 weeks after birth.Sponsors and contacts
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Loyola University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Rush University Medical Center
Collaborator
Source ClinicalTrials.gov