Happy Baby Hearts Study (NCT05842876) | Clinical Trial Compass
CompletedNot Applicable
Happy Baby Hearts Study
United States82 participantsStarted 2023-04-19
Plain-language summary
The goal of this observational study is to determine the feasibility of renal Near Infrared Spectroscopy (NIRS) monitoring in the newborn nursery for newborns at low risk of coarctation of the aorta (CoA). The main questions it aims to answer are:
* whether continuous renal NIRS monitoring is feasible;
* whether NIRS monitoring results in higher nursing and parent/caregiver satisfaction than current standard monitoring; and,
* whether participants who develop CoA will spend a smaller proportion of time within the normal range than patients who do not have CoA.
Participants will be observed through continuous renal oxygenation monitoring with NIRS.
Who can participate
Age range
15 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.
Neonate Inclusion Criteria:
* Delivered at ≥ 35 weeks of gestation
* \<12 hours of age
* Inpatient at Meriter Hospital, Inc. NICU or Newborn Nursery or AFCH PICU or NICU
* Diagnosed as at risk for CoA
Neonate Exclusion Criteria:
* Major congenital anomalies of the kidney
* Attending physician's discretion to not place sensors due to clinical concerns
* In the researcher's medical opinion, there is a significant likelihood that the neonate would not survive the first 3 days of life
Primary Caregiver Inclusion Criteria:
* Able to understand and the willing to sign a written informed consent document
* Willing to comply with all study procedures and be available for the duration of the study
* Birth parent (i.e., the parent who gave birth to the baby) who is the primary caregiver of a neonate who is eligible to participate in study
* Agrees to enroll neonate into study
* Aged 15 years or older
* Pregnant mother with a baby diagnosed prenatally as at risk for CoA will be eligible for the study. They must also meet the following criteria:
* Require an "arch watch care plan" as a results of prenatal ultrasonography findings
* Agree to enroll offspring into the study at birth
Primary Caregiver Exclusion Criteria:
* Subject is unable to provide informed consent, including subjects who are in foster care and subjects within state custody
* Pregnant woman who does not plan to maintain custody of the child after birth, such as instances of adoption or surrogacy
Newborn Nursery N…
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.
What they're measuring
1
Percent of time monitored
Timeframe: Up to 2 weeks post-delivery, on average