PretermNCT02557191
Biomarkers, Neurodevelopment and Preterm Infants
An observational study of Preterm and Neurodevelopmental Disorder, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Approximately 2% of neonates in the US are born very preterm. Preterm births are associated with impaired cognitive, language and motor function, and increased risk for autism spectrum disorders. Read more about this study
- Who is it for?
- Ages 1 day to 2 days
- Conditions the study is for
- Preterm, Neurodevelopmental Disorder, Epigenetic Changes
- What is being tested?
- Observational study
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Dec 2018
- How long will I take part?
- 2 Years
- 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 1 day to 2 days
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants <32 weeks GA
Who may be able to join
- <32 weeks" gestation
- Born at Weiler Division of Montefiore
Who cannot join
- Intraventricular hemorrhage
- Chromosomal abnormalities
- Congenital viral conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarkers to Predict Neurodevelopmental Outcomes in Very Preterm Infants
Approximately 2% of neonates in the US are born very preterm. Preterm births are associated with impaired cognitive, language and motor function, and increased risk for autism spectrum disorders. Epidemiological studies indicate a dose-response relationship between gestational age at delivery and cognitive impairments, with the most immature of newborns being the most susceptible to developmental delays. Sensitive and reproducible biomarkers of long-term neurocognitive impairments are currently lacking. The investigators seek to identify epigenetic markers that mediate the relationship between adverse prematurity-related exposures and neurocognitive impairments. The overarching hypothesis of this proposal is that DNA methylation profiles of CD34+ hematopoetic progenitor and stem cells from very preterm infants can be used as a risk-stratifying biomarker for predicting neurocognitive impairment in childhood.
- Conditions
- Preterm, Neurodevelopmental Disorder, Epigenetic Changes
- Being tested
- Observational study
- Medical subject headings
- Premature Birth, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Preterm infants <32 weeks gestational age Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain white matter development
Brain MRI
Measured: 38-42 weeks adjusted age
Secondary outcomes (2)
Neurodevelopment
Administration of NICU Neonatal Neurobehavioral Scale
Measured: 38-42 weeks adjusted age
Neurodevelopment
Administration of Bayley Scales of Infant and Toddler Development, 3rd edition
Measured: 18-24 months adjusted age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: Difficulty recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies 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
- 4 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Einstein College of Medicine
- Responsible party
- Principal investigator, Mamta Fuloria, Montefiore Medical Center
- Investigators
- Mamta Fuloria, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557191
- Sponsor's protocol ID
- 2015-4484
- Status last verified
- Apr 2019
- First submitted
- 6 Jul 2015
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers to Predict Neurodevelopmental Outcomes in Very Preterm Infants
- ClinicalTrials.gov ID
- NCT02557191
- Acronym / sponsor ID
- 2015-4484
- Conditions
- Preterm, Neurodevelopmental Disorder, Epigenetic Changes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting patients
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Albert Einstein College of Medicine
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 23 Sep 2015 (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.
Approximately 2% of neonates in the US are born very preterm. Preterm births are associated with impaired cognitive, language and motor function, and increased risk for autism spectrum disorders. Epidemiological studies indicate a dose-response relationship between gestational age at delivery and cognitive impairments, with the most immature of newborns being the most susceptible to developmental delays. Sensitive and reproducible biomarkers of long-term neurocognitive impairments are currently lacking. The investigators seek to identify epigenetic markers that mediate the relationship between adverse prematurity-related exposures and neurocognitive impairments. The overarching hypothesis of this proposal is that DNA methylation profiles of CD34+ hematopoetic progenitor and stem cells from very preterm infants can be used as a risk-stratifying biomarker for predicting neurocognitive impairment in childhood.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Observational studyPreterm infants <32 weeks gestational age |
Who may qualify
- Ages
- 1 day to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants <32 weeks GA
Key inclusion criteria (2 listed)
- <32 weeks" gestation
- Born at Weiler Division of Montefiore
Key exclusion criteria (3 listed)
- Intraventricular hemorrhage
- Chromosomal abnormalities
- Congenital viral conditions
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 |
|---|---|---|
| Observational study | Other | Group 1 |
Primary outcome
Brain white matter development
Time frame: 38-42 weeks adjusted age
Brain MRI
2 secondary outcomes
Neurodevelopment
Time frame: 38-42 weeks adjusted age
Neurodevelopment
Time frame: 18-24 months adjusted age
Results and safety
The study was stopped early (reason given: Difficulty recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 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.
Mamta Fuloria, MD principal investigator
Montefiore Medical Center
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 Preterm and Neurodevelopmental Disorder, run by Montefiore Medical Center 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 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: stopped early, as of the sponsor's last update on 25 Apr 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 was stopped early (reason given: Difficulty recruiting patients). Results are not available in the source record.
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?
Brain white matter development (time frame: 38-42 weeks adjusted 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 25 Apr 2019; AzTrials last refreshed its copy on 29 Oct 2026.