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
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome, Newborn
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
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
No
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
86
Email
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
86
Email
neuroclong@126.com
12. IPD Sharing Statement
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Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome
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