Infant DevelopmentNCT02058225
Developing Advanced MRI Methods for Detecting the Impact of Nutrients on Infant Brain Development
An observational study of Infant Development, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The purpose is to study the effect of infant nutrition on brain development, as measured using Magnetic Resonance (MR) techniques. The investigators will collect detailed information about the diet of each of the infants, and seek to correlate this information with multiple MR measurements, including structural… Read more about this study
- Who is it for?
- Ages Up to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2014to 22 May 2017
- 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 4 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The participants are recruited from two major hospitals at the bedside soon after normal delivery.
Who may be able to join
- full-term babies whose mothers have no known medical conditions or complications during pregnancy.
Who cannot join
- preterm babies
- babies whose mothers have significant medical conditions and/or significant complications during pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Waltham Imaging Center: Boston Childrens Hospital
Waltham, Massachusetts, 02453
About this study
The purpose is to study the effect of infant nutrition on brain development, as measured using Magnetic Resonance (MR) techniques. The investigators will collect detailed information about the diet of each of the infants, and seek to correlate this information with multiple MR measurements, including structural imaging, diffusion imaging, and functional connectivity. The MR scans will be performed at birth and 3 months of age. Dietary information collected will include detailed food diaries describing the feeding habits of the infants, and food frequency questionnaires to characterize the diet of the mother.
Read the detailed description
The purpose is to study the effect of infant nutrition on brain development, as measured using Magnetic Resonance (MR) techniques. The investigators will collect detailed information about the diet of each of the infants, and seek to correlate this information with multiple MR measurements, including structural imaging, diffusion imaging, and functional connectivity. The MR scans will be performed at birth and 3 months of age. Dietary information collected will include detailed food diaries describing the feeding habits of the infants, and food frequency questionnaires to characterize the diet of the mother.
- Conditions
- Infant Development
- Keywords
- Infant Nutrition, Magnetic resonance spectroscopy, Infant Brain Development, Diffusion weighted Imaging, Diffusion tensor tractography
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 |
|---|---|---|
| Infant Group 1 | This group consist of healthy, full-term babies whose mothers have no known medical conditions or complications during pregnancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Imaging to measure of brain metabolites, brain structures and brain function
Measured: Infants receive an MRI at 3 months of age
Magnetic Resonance Imaging to measure of brain metabolites, brain structures and brain function
Measured: Infants receive an MRI scan at less than 2 weeks of age
Secondary outcomes (1)
Nutritional analysis of mothers diet using a food frequency questionnaire
Measured: Mothers fill out questionnaire at three months after enrollment into the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study start1 Mar 2014
- Primary completion22 May 2017
- Study completion22 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, University of Illinois at Urbana-Champaign
- Responsible party
- Principal investigator, Ellen Grant, Boston Children's Hospital
- Investigators
- P Ellen Grant, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058225
- Sponsor's protocol ID
- 84421489-1
- Status last verified
- Jun 2017
- First submitted
- 4 Feb 2014
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zollei L, Iglesias JE, Ou Y, Grant PE, Fischl B. Infant FreeSurfer: An automated segmentation and surface extraction pipeline for T1-weighted neuroimaging data of infants 0-2 years. Neuroimage. 2020 Sep;218:116946. doi: 10.1016/j.neuroimage.2020.116946. Epub 2020 May 20.
PubMed 32442637Karmacharya S, Gagoski B, Ning L, Vyas R, Cheng HH, Soul J, Newberger JW, Shenton ME, Rathi Y, Grant PE. Advanced diffusion imaging for assessing normal white matter development in neonates and characterizing aberrant development in congenital heart disease. Neuroimage Clin. 2018 May 1;19:360-373. doi: 10.1016/j.nicl.2018.04.032. eCollection 2018.
PubMed 30013919Ferradal SL, Gagoski B, Jaimes C, Yi F, Carruthers C, Vu C, Litt JS, Larsen R, Sutton B, Grant PE, Zollei L. System-Specific Patterns of Thalamocortical Connectivity in Early Brain Development as Revealed by Structural and Functional MRI. Cereb Cortex. 2019 Mar 1;29(3):1218-1229. doi: 10.1093/cercor/bhy028.
PubMed 29425270
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Advanced MRI Methods for Detecting the Impact of Nutrients on Infant Brain Development
- ClinicalTrials.gov ID
- NCT02058225
- Acronym / sponsor ID
- 84421489-1
- Conditions
- Infant Development
- Keywords
- Infant Nutrition, Magnetic resonance spectroscopy, Infant Brain Development, Diffusion weighted Imaging, Diffusion tensor tractography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, University of Illinois at Urbana-Champaign
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 22 May 2017 (actual)
- Study completion
- 22 May 2017 (actual)
- First posted
- 10 Feb 2014 (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 is to study the effect of infant nutrition on brain development, as measured using Magnetic Resonance (MR) techniques. The investigators will collect detailed information about the diet of each of the infants, and seek to correlate this information with multiple MR measurements, including structural imaging, diffusion imaging, and functional connectivity. The MR scans will be performed at birth and 3 months of age. Dietary information collected will include detailed food diaries describing the feeding habits of the infants, and food frequency questionnaires to characterize the diet of the mother.
Detailed description
The purpose is to study the effect of infant nutrition on brain development, as measured using Magnetic Resonance (MR) techniques. The investigators will collect detailed information about the diet of each of the infants, and seek to correlate this information with multiple MR measurements, including structural imaging, diffusion imaging, and functional connectivity. The MR scans will be performed at birth and 3 months of age. Dietary information collected will include detailed food diaries describing the feeding habits of the infants, and food frequency questionnaires to characterize the diet of the mother.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infant Group 1 | – | –This group consist of healthy, full-term babies whose mothers have no known medical conditions or complications during pregnancy. |
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The participants are recruited from two major hospitals at the bedside soon after normal delivery.
Key inclusion criteria (1 listed)
- full-term babies whose mothers have no known medical conditions or complications during pregnancy.
Key exclusion criteria (2 listed)
- preterm babies
- babies whose mothers have significant medical conditions and/or significant complications during pregnancy.
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
Magnetic Resonance Imaging to measure of brain metabolites, brain structures and brain function
Time frame: Infants receive an MRI at 3 months of age
Magnetic Resonance Imaging to measure of brain metabolites, brain structures and brain function
Time frame: Infants receive an MRI scan at less than 2 weeks of age
1 secondary outcome
Nutritional analysis of mothers diet using a food frequency questionnaire
Time frame: Mothers fill out questionnaire at three months after enrollment into the study
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 22 Jun 2017.
- Derived from this study: PubMed 32442637Zollei L, Iglesias JE, Ou Y, Grant PE, Fischl B. Infant FreeSurfer: An automated segmentation and surface extraction pipeline for T1-weighted neuroimaging data of infants 0-2 years. Neuroimage. 2020 Sep;218:116946. doi: 10.1016/j.neuroimage.2020.116946. Epub 2020 May 20.
- Derived from this study: PubMed 30013919Karmacharya S, Gagoski B, Ning L, Vyas R, Cheng HH, Soul J, Newberger JW, Shenton ME, Rathi Y, Grant PE. Advanced diffusion imaging for assessing normal white matter development in neonates and characterizing aberrant development in congenital heart disease. Neuroimage Clin. 2018 May 1;19:360-373. doi: 10.1016/j.nicl.2018.04.032. eCollection 2018.
- Derived from this study: PubMed 29425270Ferradal SL, Gagoski B, Jaimes C, Yi F, Carruthers C, Vu C, Litt JS, Larsen R, Sutton B, Grant PE, Zollei L. System-Specific Patterns of Thalamocortical Connectivity in Early Brain Development as Revealed by Structural and Functional MRI. Cereb Cortex. 2019 Mar 1;29(3):1218-1229. doi: 10.1093/cercor/bhy028.
- Individual participant dataSharing planned: No
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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.
P Ellen Grant, MD principal investigator
Boston Children's Hospital
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 Infant Development, run by Boston Children's Hospital 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 1 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 22 Jun 2017. 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?
Magnetic Resonance Imaging to measure of brain metabolites, brain structures and brain function (time frame: Infants receive an MRI at 3 months of age). The study lists 2 primary outcomes in all. 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 NCT02058225, which also lists 3 linked publications.
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 22 Jun 2017.