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Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome

Primary Purpose

Respiratory Distress Syndrome, Newborn, Patent Ductus Arteriosus, Bronchopulmonary Dysplasia

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

PS is stopped when the pressure is equal between bPDA and aPDA.

PS is given according to the 2019 European RDS management guideline

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Newborn

Eligibility Criteria

1 Minute - 12 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

gestation age less than or equal to 32 weeks
PS is needed

Exclusion Criteria:

main congenital abnormalities
parents' refusal or quit

Sites / Locations

Children's Hospital of Chongqing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PS is stopped when the pressure is equal between bPDA and aPDA

PS is given according to the 2019 European RDS management guideline

Arm Description

PS is given and stopped when the pressure is equal between bPDA and aPDA. the pressure is measured using ultrasound

PS is given according to the 2019 European RDS management guideline

Outcomes

Primary Outcome Measures

the size of PDA

the size of PDA is zero

BPD and/or death

the BPD and/or death is diagnosed when the included infants remain needing oxygen at 36 week's gestational age

Secondary Outcome Measures

Full Information

NCT ID

NCT04984057

First Posted

July 24, 2021

Last Updated

October 13, 2022

Sponsor

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

Collaborators

Children's Hospital of Chongqing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04984057

Brief Title

Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome

Official Title

Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome(RDS)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2021 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

Collaborators

Children's Hospital of Chongqing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

In preterm infants with neonatal respiratory distress syndrome (RDS), exogenous pulmonary surfactant(PS) replacement therapy is one of the most important therapeutic breakthrough to reduce neonatal incidences of bronchopulmonary dysplasia(BPD) and/or death. But not all preterm infants with RDS can be beneficial. Otherwise, the international neonatal acute RDS (NARDS) collaborative group provides the first consensus definition for NARDS in 2017. And whether or not PS being beneficial in preterm infants with NARDS remains unknown.

Detailed Description

To date, the optimal dose of PS is inconsistent, although the recommended dose of PS is given in the 2019 update guideline. PS is not recommended to adult and pediatric ARDS. Systematic review indicates that PS does not reduce the incidences of BPD and death in infants with meconium aspiration syndrome(MAS, a subtype of NARDS). A reasonable speculation is that preterm infants with NARDS do not benefit from PS. And the speculation can explain why not all preterm infants with RDS can be beneficial from PS. In the era of pre-NARDS, the preterm infants fulfilling the definition of NARDS may have been considered as RDS in the first three days after birth. Meantime, the dose of PS given to infants with NARDS remains unknown. the aim of the present study is to assess the optimal dose of PS. the control group: PS is given according to the European RDS management guideline in 2019 edition. The study group: PS is stopped when the pressure is equal between before patent ductus arteriosus(bPDA) and after PDA(aPDA). the primary outcomes are the closure rate of PDA within 7 days, the incidence of BPD and/or death.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Distress Syndrome, Newborn, Patent Ductus Arteriosus, Bronchopulmonary Dysplasia, Preterm

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PS is stopped when the pressure is equal between bPDA and aPDA

Arm Type

Experimental

Arm Description

PS is given and stopped when the pressure is equal between bPDA and aPDA. the pressure is measured using ultrasound

Arm Title

PS is given according to the 2019 European RDS management guideline

Arm Type

Active Comparator

Arm Description

PS is given according to the 2019 European RDS management guideline

Intervention Type

Drug

Intervention Name(s)

PS is stopped when the pressure is equal between bPDA and aPDA.

Intervention Description

PS is given and stopped when the pressure is equal between bPDA and aPDA. the pressure is measured using ultrasound

Intervention Type

Drug

Intervention Name(s)

PS is given according to the 2019 European RDS management guideline

Intervention Description

PS is given according to the 2019 European RDS management guideline

Primary Outcome Measure Information:

Title

the size of PDA

Description

the size of PDA is zero

Time Frame

within 7 days after birth

Title

BPD and/or death

Description

the BPD and/or death is diagnosed when the included infants remain needing oxygen at 36 week's gestational age

Time Frame

at 36 week's gestational age

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Minute

Maximum Age & Unit of Time

12 Hours

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: gestation age less than or equal to 32 weeks PS is needed Exclusion Criteria: main congenital abnormalities parents' refusal or quit

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chen Long, PhD,MD

Phone

13883559467

Ext

neuroclong@126.com

Facility Information:

Facility Name

Children's Hospital of Chongqing Medical University

City

Chongqing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chen Long, PhD,MD

Phone

13883559467

Ext

neuroclong@126.com

12. IPD Sharing Statement

Learn more about this trial

Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome

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