HealthyNCT00679471
Brain Structure and Development in Pre-Term and Full-Term Infants
An observational study of Healthy, run by Christiana Care Health Services at 2 sites in United States.
Trial summary
The purpose of this study is to see how full-term and pre-term infants' brains relate to their movement and development throughout the first two years of life. All infants who participate in this study will have a magnetic resonance image (MRI) of the brain prior to discharge from the hospital. Read more about this study
- Who is it for?
- Ages Up to 30 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2007to Dec 2011
- 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 30 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pre-term or full-term infants who are admitted to the Neonatal Intensive Care Unit (NICU) at Christiana Hospital.
Who may be able to join
- Pre-term infants (< 1 Kg Birthweight)
- Full-term infants (well)
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Delaware: Infant Motor Beahvior Lab
Newark, Delaware, 19717
Christiana Hospital
Newark, Delaware, 19718
About this study
Official title: The Relationship Between Early Brain Structure and Development in Full-Term and Pre-Term Infants
The purpose of this study is to see how full-term and pre-term infants' brains relate to their movement and development throughout the first two years of life. All infants who participate in this study will have a magnetic resonance image (MRI) of the brain prior to discharge from the hospital. Infants will then have follow-up appointments every 3-6 months at home or at the Infant Motor Behavior Laboratory at the University of Delaware. The follow-up sessions will test how infants change their movements to respond to interesting objects or sounds in their environment. It is hoped that the results of this study will assist clinicians in developing better testing and treatment methods for those infants at risk for developmental problems.
- Conditions
- Healthy
- Keywords
- pre-term infants, full-term infants, MRI, brain structure development, pre term, full term
- Medical subject headings
- Premature Birth
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 |
|---|---|---|
| Pre-Term | Infants born pre-term with birthweight less than 1KG | |
| Full-Term Infants | Well infants who are born full-term |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the learning and coordination impairments of extremely low birth weight infants with full term infants at 3 and 6 months of age
To compare the learning and coordination impairments of extremely low birth weight infants with full term infants at 3 and 6 months of age. This is accomplished through a series of play activities.
Measured: 6 months
Secondary outcomes (1)
To relate the learning and coordination impairments of extremely low birth weight infants at 3 and 6 months of age to their CNS impairments at term age.
To relate the learning and coordination impairments of extremely low birth weight infants at 3 and 6 months of age to their CNS impairments at term age.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- University of Delaware
- Responsible party
- Sponsor
- Investigators
- David A. Paul, MD, Principal investigator, Christiana Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679471
- Sponsor's protocol ID
- CCC27122
- Status last verified
- Jun 2013
- First submitted
- 14 May 2008
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gadin E, Lobo M, Paul DA, Sem K, Steiner KV, Mackley A, Anzilotti K, Galloway C. Volumetric MRI and MRS and early motor development of infants born preterm. Pediatr Phys Ther. 2012 Spring;24(1):38-44. doi: 10.1097/PEP.0b013e31823e069d.
PubMed 22207464
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Early Brain Structure and Development in Full-Term and Pre-Term Infants
- ClinicalTrials.gov ID
- NCT00679471
- Acronym / sponsor ID
- CCC27122
- Conditions
- Healthy
- Keywords
- pre-term infants, full-term infants, MRI, brain structure development, pre term, full term
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Collaborators
- University of Delaware
- Study start
- Nov 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 May 2008 (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 see how full-term and pre-term infants' brains relate to their movement and development throughout the first two years of life. All infants who participate in this study will have a magnetic resonance image (MRI) of the brain prior to discharge from the hospital. Infants will then have follow-up appointments every 3-6 months at home or at the Infant Motor Behavior Laboratory at the University of Delaware. The follow-up sessions will test how infants change their movements to respond to interesting objects or sounds in their environment. It is hoped that the results of this study will assist clinicians in developing better testing and treatment methods for those infants at risk for developmental problems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Term | – | –Infants born pre-term with birthweight less than 1KG |
| Full-Term Infants | – | –Well infants who are born full-term |
Who may qualify
- Ages
- Up to 30 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pre-term or full-term infants who are admitted to the Neonatal Intensive Care Unit (NICU) at Christiana Hospital.
Key inclusion criteria (2 listed)
- Pre-term infants (< 1 Kg Birthweight)
- Full-term infants (well)
Key exclusion criteria (0 listed)
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
To compare the learning and coordination impairments of extremely low birth weight infants with full term infants at 3 and 6 months of age
Time frame: 6 months
To compare the learning and coordination impairments of extremely low birth weight infants with full term infants at 3 and 6 months of age. This is accomplished through a series of play activities.
1 secondary outcome
To relate the learning and coordination impairments of extremely low birth weight infants at 3 and 6 months of age to their CNS impairments at term age.
Time frame: 6 months
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 4 Jun 2013.
- Derived from this study: PubMed 22207464Gadin E, Lobo M, Paul DA, Sem K, Steiner KV, Mackley A, Anzilotti K, Galloway C. Volumetric MRI and MRS and early motor development of infants born preterm. Pediatr Phys Ther. 2012 Spring;24(1):38-44. doi: 10.1097/PEP.0b013e31823e069d.
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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.
David A. Paul, MD principal investigator
Christiana Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Christiana Care Health Services at 2 sites 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 0 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 4 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
To compare the learning and coordination impairments of extremely low birth weight infants with full term infants at 3 and 6 months of age (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00679471, which also lists 1 linked publication.
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 4 Jun 2013.