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Behavioural Intervention

M-MILK for Infant Development (M-MILK Trial)

N/A

Recruiting

Research Sponsored by Loyola University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

born between 22 to 28 weeks gestational age and receiving mother's own milk and/or donor milk.

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months corrected age

Awards & highlights

M-MILK Trial Summary

This trial aims to test a new intervention called M-MILK in preterm infants. Preterm infants are babies born between 22 to 28 weeks gestation age. These babies often experience toxic

Who is the study for?

This trial is for preterm infants born between 22 to 28 weeks gestational age. It's designed to help those in the NICU who are experiencing early life stress that could affect their brain development and health later on. Infants must be able to start the intervention from day 3 of life.Check my eligibility

What is being tested?

The study tests an intervention called M-MILK, which involves giving preterm infants small droplets of human milk orally, starting as early as possible after birth. The goal is to see if this can reduce stress and promote healthy brain development by mimicking natural nurturing behaviors.See study design

What are the potential side effects?

Since the intervention uses human milk given orally in a way similar to breastfeeding, side effects are expected to be minimal. However, monitoring will ensure any unexpected reactions are noted.

M-MILK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My baby was born prematurely and is being fed breast milk.

M-MILK Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months corrected age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 months corrected age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months corrected age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of intervention

Feasibility of intervention

Retention

+9 more

Secondary outcome measures

Breastfeeding rate

Breastmilk pumping rate

Variability in Parent Discharge Readiness score

+2 more

Other outcome measures

Variability in DNA methylation of HSD11B2 promoter

Variability in DNA methylation of NR3C1 promoter

Variability in gut microbial community structure and relative abundance of SCFA- and lactate- producing bacteria

M-MILK Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: M-MILKExperimental Treatment1 Intervention

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

Group II: Attention ControlActive Control1 Intervention

Infants in the attention control group will receive standard of care.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Loyola UniversityLead Sponsor

156 Previous Clinical Trials

30,922 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for participants in this study currently ongoing?

"According to the most up-to-date information on clinicaltrials.gov, this trial is currently seeking eligible participants. The initial posting of the trial occurred on October 23rd, 2023, and it was last modified on January 25th, 2024."

Answered by AI

Is the enrollment for this medical study inclusive of individuals aged 60 and above?

"This clinical study is seeking participants within the age range of greater than 0 years and less than 1 year."

Answered by AI

What is the upper limit on the number of participants enrolled in this research endeavor?

"Indeed, the information found on clinicaltrials.gov confirms that this ongoing medical trial is actively seeking eligible participants. The initial posting of the trial was made on October 23rd, 2023, and it was most recently updated on January 25th, 2024. This study aims to enroll a total of 12 patients from a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multisensory Early Oral Administration of Human Milk in Preterm Infants

2023. "Multisensory Early Oral Administration of Human Milk in Preterm Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06230848.

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