Lung DiseaseNCT00315263
Genomics, Single Nucleotide Polymorphisms (SNPs), and Clinical Neonatology
An observational study of Lung Disease and Brain Injury, run by Children's Mercy Hospital Kansas City at 2 sites in United States.
Trial summary
This research seeks to establish a neonatal DNA Tissue Bank to find out if differences in small segments of DNA predispose babies to Chronic Lung Disease (CLD), Periventricular Brain Injury (PVI), Necrotizing Enterocolitis (NEC), or Hypoxic Respiratory Failure (HRF). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Disease, Brain Injury, Necrotizing Enterocolitis
- How many people
- 63 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2006to Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Intensive Care Nursery
Who may be able to join
- Less than 34 weeks gestation and less than 1500 g at birth
- Greater than or equal to 36 weeks gestation and either with hypoxic respiratory failure or with mild respiratory distress never requiring assisted ventilation
Who cannot join
- Life threatening anomalies of any organ system (e.g., cardiac, thoracic, lethal, or non-lethal chromosomal abnormalities)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Truman Medical Center
Kansas City, Missouri, 64108
About this study
Official title: Genomics, SNPs, and Clinical Neonatology
This research seeks to establish a neonatal DNA Tissue Bank to find out if differences in small segments of DNA predispose babies to Chronic Lung Disease (CLD), Periventricular Brain Injury (PVI), Necrotizing Enterocolitis (NEC), or Hypoxic Respiratory Failure (HRF).
Read the detailed description
This genetic predisposition study does not involve investigational drugs, devices, or treatments. Our broad goal is to identify genomic factors, which contribute to the development or exacerbation of common and critical illnesses that affect preterm and near-term infants. We seek to accomplish this goal in the following ways:
- First: to test candidate gene DNA variations and link already identified single nucleotide polymorphisms (SNPs) producing functional alterations to the risk of clinically important disorders.
- Second: to utilize a whole-genomic approach to identify SNPs not previously linked to the risk of development or progression of neonatal disorders.
- Keywords
- DNA, Genomics, SNPs, Neonatology, Chronic Lung Disease, Periventricular Brain Injury, Hypoxic Respiratory Failure
- Medical subject headings
- Lung Diseases, Brain Injuries, Enterocolitis, Necrotizing, Respiratory Insufficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionOct 2008
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseaseStudies 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas
- Investigators
- William E Truog, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315263
- Sponsor's protocol ID
- 01.3965
- Status last verified
- Aug 2011
- First submitted
- 14 Apr 2006
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomics, SNPs, and Clinical Neonatology
- ClinicalTrials.gov ID
- NCT00315263
- Acronym / sponsor ID
- 01.3965
- Keywords
- DNA, Genomics, SNPs, Neonatology, Chronic Lung Disease, Periventricular Brain Injury, Hypoxic Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- University of Kansas
- Study start
- Apr 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 18 Apr 2006 (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.
This research seeks to establish a neonatal DNA Tissue Bank to find out if differences in small segments of DNA predispose babies to Chronic Lung Disease (CLD), Periventricular Brain Injury (PVI), Necrotizing Enterocolitis (NEC), or Hypoxic Respiratory Failure (HRF).
Detailed description
This genetic predisposition study does not involve investigational drugs, devices, or treatments. Our broad goal is to identify genomic factors, which contribute to the development or exacerbation of common and critical illnesses that affect preterm and near-term infants. We seek to accomplish this goal in the following ways:
- First: to test candidate gene DNA variations and link already identified single nucleotide polymorphisms (SNPs) producing functional alterations to the risk of clinically important disorders.
- Second: to utilize a whole-genomic approach to identify SNPs not previously linked to the risk of development or progression of neonatal disorders.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Intensive Care Nursery
Key inclusion criteria (2 listed)
- Less than 34 weeks gestation and less than 1500 g at birth
- Greater than or equal to 36 weeks gestation and either with hypoxic respiratory failure or with mild respiratory distress never requiring assisted ventilation
Key exclusion criteria (1 listed)
- Life threatening anomalies of any organ system (e.g., cardiac, thoracic, lethal, or non-lethal chromosomal abnormalities)
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
Not reported in the source record.
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 26 Aug 2011.
- Official Web Address of sponsoring organizationLink provided by the sponsor.
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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.
William E Truog, MD principal investigator
Children's Mercy Hospital Kansas City
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 Lung Disease and Brain Injury, run by Children's Mercy Hospital Kansas City 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 1 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 26 Aug 2011. 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.
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 26 Aug 2011.