Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
218 participants
INTERVENTIONAL
2012-07-31
2017-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Infants are randomized to usual care or the intervention which uses automated daily phone calls and 2 virtual home visits each week. Weights, oxygen levels, and amount of food taken are obtained by the primary caregiver (parent) daily and sent via automated phone call, text message or email messages based on primary caregiver's desired.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Daily Messages, virtual home visits
Intervention includes: Measuring daily weights, 24 hour intake, heart rate, oxygen level
Daily messages requesting weight, intake, pulse ox and pulse are automated
Virtual home visits occur twice weekly where the investigators see the infant and families.
Daily Messages, Virtual Home Visits
Intervention includes: Measuring daily weights, 24 hour intake, heart rate, oxygen level
Daily messages requesting weight, intake, pulse ox and pulse are automated
Virtual home visits occur twice weekly where the investigators see the infant and families.
Usual Care
Infants will have usual care as defined by cardiology.
Usual Care
Usual care as defined by by the Cardiology Department.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Daily Messages, Virtual Home Visits
Intervention includes: Measuring daily weights, 24 hour intake, heart rate, oxygen level
Daily messages requesting weight, intake, pulse ox and pulse are automated
Virtual home visits occur twice weekly where the investigators see the infant and families.
Usual Care
Usual care as defined by by the Cardiology Department.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of congenital heart disease,
* Post menstrual age 37 weeks and older;
* Minimum birth weight 2500 grams,
* At least one parent speaks and reads English,
* Anticipated discharge by 21 days of life
Exclusion Criteria
* Diagnosis of Genetic syndrome
2 Weeks
5 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Children's Hospital Medical Center, Cincinnati
OTHER
National Institutes of Health (NIH)
NIH
Children's Hospital of Philadelphia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Barbara Medoff-Cooper, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of PHiladelphia
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lisanti AJ, Golfenshtein N, Min J, Medoff-Cooper B. Early growth trajectory is associated with psychological stress in parents of infants with congenital heart disease, but moderated by quality of partner relationship. J Pediatr Nurs. 2023 Mar-Apr;69:93-100. doi: 10.1016/j.pedn.2022.12.016. Epub 2023 Jan 23.
Golfenshtein N, Lisanti AJ, Cui N, Cooper BM. Predictors of Post-traumatic stress symptomology in parents of infants with Congenital Heart Disease post-surgery and after four months. J Pediatr Nurs. 2022 Jan-Feb;62:17-22. doi: 10.1016/j.pedn.2021.11.013. Epub 2021 Nov 25.
Medoff Cooper B, Marino BS, Fleck DA, Lisanti AJ, Golfenshtein N, Ravishankar C, Costello JM, Huang L, Hanlon AL, Curley MAQ. Telehealth Home Monitoring and Postcardiac Surgery for Congenital Heart Disease. Pediatrics. 2020 Sep;146(3):e20200531. doi: 10.1542/peds.2020-0531.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
11-008246
Identifier Type: -
Identifier Source: org_study_id