Last reviewed · How we verify
NCT03867903
BabySparks Developmental Application Pilot Study
trial testing Babysparks Application in Development, Child in 66 participants. Completed in 17 May 2023.
25 December 2021
Quick facts
| Lead sponsor | Children's Mercy Hospital Kansas City |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 66 |
| Start date | 14 March 2019 |
| Primary completion | 25 December 2021 |
| Estimated completion | 17 May 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Babysparks Application
- pre and post-test Redcap Survey
Conditions studied
- Development, Child — all drugs for Development, Child →
- Adherence, Patient — all drugs for Adherence, Patient →
- Congenital Heart Disease — all drugs for Congenital Heart Disease →
Sponsor
Children's Mercy Hospital Kansas City
Who can join
Under 18 Months, any sex, with Development, Child or Adherence, Patient. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A single site, cross-sectional, pilot study of a mHealth application. Primary Objective This purpose of this pilot study is to evaluate mHealth adherence to a developmental application, Babysparks©, by parents of infants with complex congenital cardiac disease and single ventricle heart disease. Secondary Objective(s) -To determine the demographic and infant characteristics that correlate with mHealth adherence. -The rate of developmental progress of milestones while using the application will also be compared between infants with single ventricle cardiac disease and bi-ventricular cardiac disease. Research Intervention(s)/ Investigational Agent(s) Babysparks© developmental application is the main intervention with evaluation on feasibility of the mHealth application in a pediatric cardiology population. Study participants will be parents of infants with single ventricle and bi-ventricular complex congenital heart disease who underwent cardiac surgery in the first six weeks of life and are currently less than 18 months of age. Study Population There are approximately 150 new patients a year who have undergone cardiac surgery, with an additional 150 who are 18 months of age or less. Sample Size A maximum of 400 families/year Study Duration for Individual Participants Study participants will be monitored for a minimum of 6 months with the use of the BabySparks© App; to a maximum of 24 months of use of the app or when the child reaches a developmental age of 24 months, whichever occurs first. Study Specific Abbreviations/ Definitions mHealth : mobile health CHD: Congenital heart disease
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03867903
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03867903 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Mercy Hospital Kansas City
- Last refreshed: 18 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03867903.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing