Surfactant for Neonatal Respiratory Distress Syndrome at... | NCT03479450

Studies
Surfactant for Neonatal Respiratory Distress Syndrome at High Altitude Areas:a Prospective Cohort Study

NCT03479450

Sponsor

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

Status

Unknown status

Last Update Posted

Feb 17, 2021Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Surfactant

Interventions

surfactant

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Actual

Primary Completion Date

Dec 1, 2022Estimated

Completion Date

Dec 1, 2022Estimated

First Submitted Date

Mar 18, 2018

First Submission Date that Met QC Criteria

Mar 24, 2018

First Posted Date

Mar 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2021

Last Update Posted Date

Feb 17, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ma Juan, Principal Investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityPrincipal Investigator

Lead Sponsor

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

Collaborators

Name	Class
the first people hospital of Tibet autonomous region	UNKNOWN
the second people hospital of Lasa	UNKNOWN
the first people hospital of Shigatse	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The traditional concept believes that the etiology of neonatal respiratory distress syndrome (RDS) is immature development of lung,especially the surfactant synthesis system,and RDS is still one of the major causes of mortality and morbidity in newborns, especially premature infants.In recent years, using pulmonary surfactant replacement therapy (PS treatment) in the treatment of respiratory distress syndrome (RDS) is a major breakthrough in neonatal medicine.Combined with clinical practice and experience,and through Meta analysis of related randomized controlled trials (RCTs),it confirms that natural surfactant treatment can reduce mortality,the incidence of pulmonary air leaks (pneumothorax and interstitial lung emphysema),and the incidence of bronchopulmonary dysplasia (BPD) or 28-day-old mortality.For RDS in preterm infants whose gestation is <35 weeks ,surfactant replacement therapy is also more effective than in nearly term and full term infants.Therefore, in the analysis of cases of different gestational age groups,the investigators should focus on the study of premature infants cases.Due to less relevant research for using PS treatment to cure newborn RDS in high altitude area,this retrospective study conducts statistics and analysis of recently three-year cases in some hospital of high altitude area,to explore the treatment effect of the high altitude region and the impact of altitude on the treatment.

Detailed Description

in order to explore feasibility and efficacy for PS treatment of newborn RDS in high-altitude area ,and its efficacy at different altitudes, the investigators conduct a multi-center retrospective study of RDS cases in Qinghai and Tibet these two high-altitude area,and use RDS cases under the unique conditions to do statistics and analysis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surfactant	Drug	surfactant is given when neonatal respiratory distress syndrome is diagnosed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
bronchopulmonary dysplasia(BPD)	the incidence of BPD in infants with neonatal neonatal RDS	before discharge or 36 weeks' gestational age
death	the incidence of BPD in infants with neonatal RDS	before discharge or 36 weeks' gestational age

Secondary Outcomes

Measure	Description	Time Frame
intraventriclular hemorrhage(IVH)	the incidence of IVH in infants with neonatal RDS	before discharge or 36 weeks' gestational age
necrotizing enterocolitis(NEC)	the incidence of NEC in infants with neonatal RDS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

the preterm infants less than 37 weeks were included in the study;diagnosed with NRDS

Exclusion Criteria:

parents' rejecting to join;major congenital abnormalities

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Minutes

Maximum Age

1 Day

Standard Ages

Child

Study Population

the preterm infants less than 37 weeks and diagnosed with NRDS were included in the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ma Juan, MD	Contact	13508300283		petshi530@vip.163.com
Chen Long, PhD,MD	Contact	13883559467		476679422@qq.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Pediatrics, Daping Hospital, Third Military Medical University	Recruiting	Chongqing	Chongqing Municipality	400042	China

Intervention Browse Module

MeSH Terms

ID	Term
D013501	Surface-Active Agents

Ancestor Terms

ID	Term
D020313	Specialty Uses of Chemicals
D020164	Chemical Actions and Uses

Browse Leaves

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Browse Branches

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