Congenital Heart DiseaseDAISYNCT02700646
Improving Motor Skill Development in Infants After Cardiac Surgery
A study testing Developmental recommendations in people with Congenital Heart Disease, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to learn more about developmental behaviors and to examine changes in developmental progress related to motor activities among a group of infants who received open heart surgery within the first three months of life. Read more about this study
- Who is it for?
- Ages Up to 120 days
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Developmental recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2016to 13 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All hospitalized infants under age 4 months having cardiac surgery before age 3 months
- Intubation >/= 24 hours </= 14 days
Who cannot join
- Prematurity </= 36 weeks gestation
- Pre-operative clinical evidence of a central nervous system (CNS) anomaly or history of CNS insult
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to learn more about developmental behaviors and to examine changes in developmental progress related to motor activities among a group of infants who received open heart surgery within the first three months of life.
Read the detailed description
Congenital heart disease (CHD) and the need for life-saving heart surgery and intensive care during infancy may have effects on infant behavior and development. Children who require open heart surgery before their first birthday are vulnerable to developmental delays, especially related to motor skills (mobility) in the first year of life. Early delays in gross motor functioning (e.g., rolling, crawling, walking) have implications for learning and psychosocial development through adulthood. To date, no interventions to improve the gross motor functioning of children born with CHD have been developed. The purpose of this study is to learn more about developmental behaviors and to examine changes in developmental progress related to motor activities among a group of infants who received open heart surgery within the first three months of life. Activities will be tailored based on the individual infant's motor ability and medical status.
- Conditions
- Congenital Heart Disease
- Being tested
- Developmental recommendations, Standard care
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Developmental recommendationsBehavioural
Standard careBehavioural
standard care
| Study group | Role | What they receive |
|---|---|---|
| standard care | No intervention | Standard care comparison |
| inpatient | Experimental | Inpatient recommendations to parents regarding infant motor activities Receives: Behavioral: Developmental recommendations; Behavioral: Standard care |
| inpatient/outpatient | Experimental | Inpatient and outpatient recommendations to parents regarding infant motor activities Receives: Behavioral: Developmental recommendations; Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Scale score
Alberta Infant Motor Scale (AIMS) score
Measured: 3 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study start5 Jan 2016
- Primary completion13 May 2019
- Study completion13 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Uzark, University of Michigan
- Investigators
- Karen Uzark, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700646
- Sponsor's protocol ID
- HUM00107611
- Acronym
- DAISY
- Status last verified
- Aug 2019
- First submitted
- 2 Mar 2016
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Motor Skill Development in Infants After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02700646
- Acronym / sponsor ID
- DAISY / HUM00107611
- Conditions
- Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 5 Jan 2016 (actual)
- Primary completion
- 13 May 2019 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 7 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn more about developmental behaviors and to examine changes in developmental progress related to motor activities among a group of infants who received open heart surgery within the first three months of life.
Detailed description
Congenital heart disease (CHD) and the need for life-saving heart surgery and intensive care during infancy may have effects on infant behavior and development. Children who require open heart surgery before their first birthday are vulnerable to developmental delays, especially related to motor skills (mobility) in the first year of life. Early delays in gross motor functioning (e.g., rolling, crawling, walking) have implications for learning and psychosocial development through adulthood. To date, no interventions to improve the gross motor functioning of children born with CHD have been developed. The purpose of this study is to learn more about developmental behaviors and to examine changes in developmental progress related to motor activities among a group of infants who received open heart surgery within the first three months of life. Activities will be tailored based on the individual infant's motor ability and medical status.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard care | No intervention | –Standard care comparison |
| inpatient | Experimental | Behavioral: Developmental recommendations, Behavioral: Standard careInpatient recommendations to parents regarding infant motor activities |
| inpatient/outpatient | Experimental | Behavioral: Developmental recommendations, Behavioral: Standard careInpatient and outpatient recommendations to parents regarding infant motor activities |
Who may qualify
- Ages
- Up to 120 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All hospitalized infants under age 4 months having cardiac surgery before age 3 months
- Intubation >/= 24 hours </= 14 days
Key exclusion criteria (2 listed)
- Prematurity </= 36 weeks gestation
- Pre-operative clinical evidence of a central nervous system (CNS) anomaly or history of CNS insult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Developmental recommendations | Behavioural | inpatient, inpatient/outpatient |
| Standard carestandard care | Behavioural | inpatient, inpatient/outpatient |
Primary outcome
Gross Motor Scale score
Time frame: 3 months after hospital discharge
Alberta Infant Motor Scale (AIMS) score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Uzark, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Developmental recommendations in people with Congenital Heart Disease, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Scale score (time frame: 3 months after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019.