Improving access to mother's milk for very low birth weight infants
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
This study is testing if giving hospital-grade breast pumps to mothers of very low birth weight babies can help them provide more of their own milk to improve their infants' health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 611 (estimated) |
| Sex | All |
| Sponsor | Rush University Medical Center Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04540575 on ClinicalTrials.gov |
What this trial studies
This trial aims to address the disparity in the receipt of mother's own milk (MOM) among very low birth weight (VLBW) infants, particularly focusing on black mothers who face significant barriers. The intervention involves providing hospital-grade electric breast pumps to mothers to facilitate pumping and transporting milk to the neonatal intensive care unit (NICU). By evaluating the effectiveness of this intervention, the study seeks to reduce the economic and logistical burdens on mothers, ultimately improving the health outcomes for their infants. The trial will also include an economic analysis to assess the feasibility and potential for broader implementation of the findings.
Who should consider this trial
Good fit: Ideal candidates for this study are mothers who are 18 years or older, US citizens or legal residents, and are delivering or have delivered a VLBW infant (gestational age < 32 weeks).
Not a fit: Patients who may not benefit from this study include those with health conditions incompatible with milk provision or those who are COVID-19 positive and unable to visit the NICU.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the rates of mother's own milk feedings for VLBW infants, leading to better health outcomes and reduced long-term morbidities.
How similar studies have performed: Other studies have shown success in interventions aimed at improving breastfeeding rates among disadvantaged populations, suggesting that this approach may also yield positive results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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.
Where this trial is running
Chicago, Illinois
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Aloka L Patel, MD — Rush University Medical Center, Department of Pediatrics
- Study coordinator: Aloka L Patel, MD
- Email: aloka_patel@rush.edu
- Phone: (312) 942-6640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.