NCT02333669

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 3, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
Last Updated

January 7, 2015

Status Verified

January 1, 2015

Enrollment Period

2.4 years

First QC Date

January 3, 2015

Last Update Submit

January 6, 2015

Conditions

Neonatal Respiratory Distress Syndrome

Keywords

Lung fluid absorption disordersNeonatal respiratory distress syndromeSingle nucleotide polymorphismSCNN1A

Outcome Measures

Primary Outcomes (1)

  • Genotype distributions of target SNPs in RDS group and Control group

    Compare the genotype and allele frequencies of target SNPs between RDS group and the control group

    within 28 days after birth

Study Arms (2)

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

Other: 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

Other: no intervention

Interventions

no interventionOTHER

no intervention

Control groupRDS group

Eligibility Criteria

Age1 Minute - 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • Newborns with RDS

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of pediatrics, Daping Hospital, The Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Yuan Shi

    Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study Record Dates

First Submitted

January 3, 2015

First Posted

January 7, 2015

Study Start

January 1, 2012

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

January 7, 2015

Record last verified: 2015-01

Locations

CN(1)