Feeding and Transition to Home for Preterms at Social Risk (NCT02041923) | Clinical Trial Compass
CompletedNot Applicable
Feeding and Transition to Home for Preterms at Social Risk
United States198 participantsStarted 2007-01
Plain-language summary
Premature infants are at high risk of suboptimal health and development. This randomized clinical trial evaluated the impact of a developmentally based intervention, H-HOPE (Hospital-home transition: optimizing prematures' environment), for infants born between 29-34 weeks gestational age (GA) with at least two social-environmental risk factors. H-HOPE will improve infant behavior, mother care for the infants, mother-infant interaction and will reduce health care costs.
Who can participate
Age range
2 Hours – 45 Years
Sex
ALL
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:
29-34 weeks gestation at birth
no other major health problems
mothers have at least 2 socio-environmental risk factors such as African American or Latina
Less then high school education
history of mental illness
less than 150% poverty level
2 children less than 24 months old
4 or more children living in the home
living in a disadvantaged neighborhood
Exclusion Criteria:
Infant has congenital anomaly
Necrotizing enterocolitis
Brain injury
chronic lung disease
prenatal drug exposure
mother is an illicit drug user
mother is not the legal guardian
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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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.