Medically Complex InfantsCIMANCT01659710
Effects of Medical Complexity Using GMA on Lurie Children's In- and Outpatients
An observational study of Medically Complex Infants, run by Raye Ann deRegnier at 1 site in United States.
Trial summary
The purpose of this study is to research a new type of test for cerebral palsy that can be performed earlier, at 10-15 weeks of age (after the due date for premature infants). The test involves a standardized video recording of a baby's natural movements for about 10 minutes. Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Medically Complex Infants
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to 31 Jan 2019
- Phase
- Observational
- 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 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children's Memorial ICU Patients and Graduates
Who may be able to join
- Admitted to the NICU/CICU and remain hospitalized at 10-15 weeks postmenstrual age
- Birth at <28 weeks gestation
- Birth weight <1000 grams
- Neurologic risk factors (HIE, abnormal imaging, neonatal seizures, microcephaly)
- Cardiac surgery during first 3 months of life
- Severe chronic lung discharge defined as the need for mechanical ventilation at 36 weeks post-menstrual age
- Discharged home on supplemental oxygen (or if still hospitalized, requiring oxygen at 44 weeks post-menstrual age)
Who cannot join
- Significant malformations/amputations of the extremities
- Recovering from a surgical procedure within 4 weeks of the assessment
- Physiologic instability precluding movement of the hospital bed or peripheral IV lines that might affect movement of an extremity medication for the purpose of ongoing sedation
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: Effects of Medical Complexity on the Development of Fidgety Movements and Feasibility of Screening Utilizing the General Movement Assessment for Lurie Children's ICU Patients and Graduates
The purpose of this study is to research a new type of test for cerebral palsy that can be performed earlier, at 10-15 weeks of age (after the due date for premature infants). The test involves a standardized video recording of a baby's natural movements for about 10 minutes. The video recorded movements are evaluated by a special trained observer and also by a computer program. There are some small studies from Europe that suggest that this type of evaluation may be accurate in early diagnosis of cerebral palsy. However, the investigators do not know if this type of evaluation is reliable in large groups of infants, including infants from Children's Memorial Hospital, who tend to be sicker and have more complicated illnesses than many of the European infants. The investigators would therefore like to evaluate whether this type of video recording could be used in the future for early diagnosis of cerebral palsy.
- Conditions
- Medically Complex Infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Babies | Study video at 50-55 weeks gestational age, motor assessments at 24m (+/- 6 months) and again at 4 years (+/- 1 year). | |
| Control Babies | Video at 50-55 weeks gestational age, motor assessment at 24 months (+/- 6 months). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of cerebral palsy
Measured: 24 months (+/- 6 months) and 4 years (+/- 1 year) of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startJan 2012
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medically Complex InfantsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raye Ann deRegnier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Raye Ann deRegnier, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- RayeAnn deRegnier, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659710
- Sponsor's protocol ID
- 2012-14808
- Acronym
- CIMA
- Status last verified
- Feb 2019
- First submitted
- 5 Aug 2012
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Medical Complexity on the Development of Fidgety Movements and Feasibility of Screening Utilizing the General Movement Assessment for Lurie Children's ICU Patients and Graduates
- ClinicalTrials.gov ID
- NCT01659710
- Acronym / sponsor ID
- CIMA / 2012-14808
- Conditions
- Medically Complex Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Raye Ann deRegnierUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 8 Aug 2012 (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 research a new type of test for cerebral palsy that can be performed earlier, at 10-15 weeks of age (after the due date for premature infants). The test involves a standardized video recording of a baby's natural movements for about 10 minutes. The video recorded movements are evaluated by a special trained observer and also by a computer program. There are some small studies from Europe that suggest that this type of evaluation may be accurate in early diagnosis of cerebral palsy. However, the investigators do not know if this type of evaluation is reliable in large groups of infants, including infants from Children's Memorial Hospital, who tend to be sicker and have more complicated illnesses than many of the European infants. The investigators would therefore like to evaluate whether this type of video recording could be used in the future for early diagnosis of cerebral palsy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Babies | – | –Study video at 50-55 weeks gestational age, motor assessments at 24m (+/- 6 months) and again at 4 years (+/- 1 year). |
| Control Babies | – | –Video at 50-55 weeks gestational age, motor assessment at 24 months (+/- 6 months). |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children's Memorial ICU Patients and Graduates
Key inclusion criteria (7 listed)
- Admitted to the NICU/CICU and remain hospitalized at 10-15 weeks postmenstrual age
- Birth at <28 weeks gestation
- Birth weight <1000 grams
- Neurologic risk factors (HIE, abnormal imaging, neonatal seizures, microcephaly)
- Cardiac surgery during first 3 months of life
Key exclusion criteria (3 listed)
- Significant malformations/amputations of the extremities
- Recovering from a surgical procedure within 4 weeks of the assessment
- Physiologic instability precluding movement of the hospital bed or peripheral IV lines that might affect movement of an extremity medication for the purpose of ongoing sedation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of cerebral palsy
Time frame: 24 months (+/- 6 months) and 4 years (+/- 1 year) of age
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 12 Nov 2024.
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.
RayeAnn deRegnier, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medically Complex Infants, run by Raye Ann deRegnier 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 7 inclusion and 3 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 12 Nov 2024. 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?
Presence of cerebral palsy (time frame: 24 months (+/- 6 months) and 4 years (+/- 1 year) of age). 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 12 Nov 2024.