Association of SCNN1A Single Nucleotide Polymorphisms With Neonatal Respiratory Distress Syndrome

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

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

    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Department of pediatrics, Daping Hospital, The Third Military Medical University

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
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
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
Compare the genotype and allele frequencies of target SNPs between RDS group and the control group
within 28 days after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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