RECRUITING

Reducing Disparity in Receipt of Mother's Own Milk in Very Low Birth Weight Infants

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In the US, the burden of very low birth weight (VLBW; \<1500 g) birth is borne disproportionately by black (non-Hispanic black/African American) mothers who are 2.2-2.6 times more likely than nonblack mothers to deliver VLBW infants. This disparity is amplified because black VLBW infants are significantly less likely to receive mother's own milk (MOM) feedings from birth until neonatal intensive care unit (NICU) discharge than nonblack infants, which adds to the lifelong burden of VLBW birth with increased risk of morbidities and greater costs. Pumping is associated with out-of-pocket and opportunity costs that are borne by mothers, unlike donor human milk and formula, which are paid for by NICUs. This innovative trial will determine the effectiveness of the intervention in reducing the disparity in MOM feedings and provide an economic analysis of the interventions, yielding critical data impacting generalizability and likelihood of implementation of results. The investigators hypothesize that mothers who receive intervention will have greater pumping volume and duration and their infants will be more likely to receive MOM at NICU discharge compared to mothers who receive standard of care lactation care and their infants.

Official Title

Reducing Disparity in Receipt of Mother's Own Milk in Very Low Birth Weight Infants: An Economic Intervention to Improve Adherence to Sustained Maternal Breast Pump Use

Quick Facts

Study Start:2020-12-03
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04540575

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * INFANT: Birth gestational age (GA)\< 32 0/7 weeks, no significant congenital anomalies or chromosomal defects, \<144 hours of age at enrollment, multiples may be included
  1. * Mothers with health conditions that are incompatible with milk provision per the clinical judgment of the NICU attending caring for the infant, mother is less than 18 years of age, mother has participated in this study with a previous pregnancy, mother is enrolled in another study that impacts lactation, in the neonatologist's opinion the infant is unlikely to survive, or mother is coronavirus (COVID-19) positive and unable to visit the NICU due to quarantine or infection-control requirements during the 144-hour post-delivery randomization window.

Contacts and Locations

Study Contact

Aloka L Patel, MD
CONTACT
(312) 942-6640
aloka_patel@rush.edu
Tricia J Johnson, PhD
CONTACT
(312) 942-5402
tricia_j_johnson@rush.edu

Principal Investigator

Aloka L Patel, MD
PRINCIPAL_INVESTIGATOR
Rush University Medical Center, Department of Pediatrics
Tricia J Johnson, PhD
PRINCIPAL_INVESTIGATOR
Rush University Medical Center, Department of Health Systems Management

Study Locations (Sites)

Rush University Medical Center
Chicago, Illinois, 60612
United States

Collaborators and Investigators

Sponsor: Rush University Medical Center

  • Aloka L Patel, MD, PRINCIPAL_INVESTIGATOR, Rush University Medical Center, Department of Pediatrics
  • Tricia J Johnson, PhD, PRINCIPAL_INVESTIGATOR, Rush University Medical Center, Department of Health Systems Management

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-03
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2020-12-03
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Race/ethnicity
  • Mother's Own Milk
  • Disparity
  • Economic

Additional Relevant MeSH Terms

  • Pumping, Breast
  • Milk, Human
  • Infant, Very Low Birth Weight
  • Preterm Birth