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Increasing Mother's Own Milk Feeding for Very Low Birth Weight Infants (ReDiMOM Trial)
N/A
Recruiting
Led By Aloka L Patel, MD
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
MATERNAL: Delivery, or anticipated delivery, of infant with gestational age < 32 0/7 weeks at Rush, age ≥18 years, US citizen or legal resident, fluent in English or Spanish
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 10 weeks
Awards & highlights
ReDiMOM Trial Summary
This trial will determine whether an intervention can reduce the disparity in mother's own milk (MOM) feedings for black infants who are very low birth weight (VLBW; <1500 g).
Who is the study for?
This trial is for black mothers over 18, US citizens or legal residents fluent in English/Spanish, who deliver or expect to deliver a baby under 32 weeks gestation without significant anomalies. The baby must be under 144 hours old at enrollment. Excluded are mothers with health issues preventing milk provision, those under 18, previously enrolled in this study with another pregnancy, involved in other lactation studies, or COVID-19 positive and unable to visit the NICU.Check my eligibility
What is being tested?
The trial tests if providing mother's own milk (MOM) reduces disparities in VLBW infants receiving MOM at NICU discharge compared to standard care. It will assess pumping volume/duration and economic aspects of interventions to understand implementation potential.See study design
What are the potential side effects?
Since the intervention involves breast milk pumping and handling rather than medication or medical procedures, traditional side effects are not applicable. However, there may be emotional or physical discomfort associated with increased pumping efforts.
ReDiMOM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18, a US citizen or resident, and speak English or Spanish. My baby was or will be born before 32 weeks of pregnancy.
ReDiMOM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Receipt of MOM at NICU Discharge
Secondary outcome measures
Cumulative dose of MOM feedings
Duration of MOM feedings
Duration of MOM pumped
+5 moreReDiMOM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NICU Acquires MOMExperimental Treatment2 Interventions
Receive economic interventions in addition to Rush NICU standard of care lactation support
Group II: Mother Provides MOMActive Control1 Intervention
Receive Rush NICU standard of care lactation support
Find a Location
Who is running the clinical trial?
National Institute on Minority Health and Health Disparities (NIMHD)NIH
383 Previous Clinical Trials
1,215,748 Total Patients Enrolled
2 Trials studying Premature Birth
322 Patients Enrolled for Premature Birth
Ohio State UniversityOTHER
830 Previous Clinical Trials
505,133 Total Patients Enrolled
6 Trials studying Premature Birth
2,436 Patients Enrolled for Premature Birth
Rush University Medical CenterLead Sponsor
422 Previous Clinical Trials
162,890 Total Patients Enrolled
1 Trials studying Premature Birth
490 Patients Enrolled for Premature Birth
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18, a US citizen or resident, and speak English or Spanish. My baby was or will be born before 32 weeks of pregnancy.My baby was born before 32 weeks, is under 6 days old, and doesn't have major birth defects.I am a mother and under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Mother Provides MOM
- Group 2: NICU Acquires MOM
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial currently inviting volunteers to participate?
"Clinicaltrials.gov data suggests that this clinical trial is presently recruiting participants, since its inaugural posting on December 3rd 2020 and most recent update on November 17th 2022."
Answered by AI
How many participants have been admitted to this clinical experiment?
"Affirmative. Clinicaltrials.gov displays that this experiment, which was initiated on December 3rd 2020, is presently recruiting patients. 611 individuals need to be enlisted at one single site of study."
Answered by AI
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