- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02333669
Association of SCNN1A Single Nucleotide Polymorphisms With Neonatal Respiratory Distress Syndrome
January 6, 2015 updated by: Li Wang, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Lung fluid absorption disorders are largely mediated by transepithelial Na+ reabsorption through alpha epithelial sodium channels (α-ENaCs) in alveolar epithelial cells.
Increasing evidence has demonstrated that these lung disorders might be an important cause of neonatal respiratory distress syndrome (NRDS) by influencing gas exchange or surfactant function, particularly in near-term and term infants.
The SCNN1A gene, which encodes the α-ENaC, might predispose infants to NRDS.
To explore whether the single-nucleotide polymorphisms (SNPs) of SCNN1A are associated with NRDS, we conducted a case-control study to investigate the NRDS-associated loci in Han Chinese infants.
Seven target SNPs were selected from the SCNN1A gene and were genotyped using the improved multiplex ligase detection reaction (iMLDR).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
249
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Chongqing
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Chongqing, Chongqing, China, 400042
- Department of pediatrics, Daping Hospital, The Third Military Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 minute to 4 weeks (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Newborns with RDS are consecutively recruited for this study from the neonatal intensive care unit (NICU) at Daping Hospital, Third Military Medical University, Chongqing, China, a tertiary care facility.
The control blood samples, which are collected from healthy neonatal umbilical cord blood, are obtained from the maternity ward of 80 hospitals in Chongqing and nearby areas.
Description
Inclusion Criteria:
- Newborns with RDS
Exclusion Criteria:
- The infants were excluded if they had any congenital malformation, inherited metabolic abnormalities, intrauterine infection, Rh/Rh incompatibility, pneumonia, pulmonary hypertension, meconium aspiration syndrome, or asphyxia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control group
The control blood samples, which were collected from healthy neonatal umbilical cord blood, were obtained from the maternity ward of 80 hospitals in Chongqing and nearby areas
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no intervention
|
RDS group
Newborns with RDS were consecutively recruited for this study from the neonatal intensive care unit (NICU) at Daping Hospital, Third Military Medical University, Chongqing, China, a tertiary care facility
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no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Genotype distributions of target SNPs in RDS group and Control group
Time Frame: within 28 days after birth
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Compare the genotype and allele frequencies of target SNPs between RDS group and the control group
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within 28 days after birth
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yuan Shi, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
January 3, 2015
First Submitted That Met QC Criteria
January 6, 2015
First Posted (Estimate)
January 7, 2015
Study Record Updates
Last Update Posted (Estimate)
January 7, 2015
Last Update Submitted That Met QC Criteria
January 6, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DapingH023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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