Improving Lactation Success in Mothers of Critically Infants (NCT04097860) | Clinical Trial Compass
CompletedNot Applicable
Improving Lactation Success in Mothers of Critically Infants
United States122 participantsStarted 2020-12-01
Plain-language summary
The purpose of this study is to determine the feasibility and potential benefits of a mHealth intervention to increase BM pumping frequency and BM production in mothers delivering critically ill infants admitted to the neonatal intensive care unit
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* stated intent to provide BM to the infant
* infant not expected to be stable enough to bottle/breastfeed for \> 14 days
* owns a mobile phone with unrestricted SMS capability.
* English speaking
Exclusion Criteria:
* known illicit drug use
* breast reduction or augmentation
* positive HIV status
* does not anticipate being able to bring BM to the NICU at least 4X/week
* infant not expected to live \> 7 days following delivery
* COVID-19 positive
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focused on breast pumping for mothers of critically ill infants — if my baby is or was in a critical care setting, is the kind of lactation support studied here something my care team could offer or connect me with now that the trial is completed?
2The trial measured breast milk volume as its main outcome — can you tell me what the results showed, and whether the pumping strategies or interventions tested actually led to meaningful increases in milk supply for mothers in this situation?
3Since this was a completed trial rather than an ongoing one, are there updated clinical guidelines or real-world practices that came out of this research that your team is already using in the NICU or ICU setting?
4Pumping for a critically ill infant can be physically and emotionally demanding — based on what this trial studied, what kind of schedule, support, or resources would be realistic for someone in my circumstances to maintain milk production?
5Are there other ongoing studies or standard lactation support programs I should know about that might be a better fit for where I am right now in my journey?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.