Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome

Sponsor

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

Overall Status

Recruiting

CT.gov ID

NCT04984057

Collaborator

Children's Hospital of Chongqing Medical University (Other)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome, Newborn Patent Ductus Arteriosus Bronchopulmonary Dysplasia Preterm	Drug: PS is stopped when the pressure is equal between bPDA and aPDA. Drug: PS is given according to the 2019 European RDS management guideline	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PS is stopped when the pressure is equal between bPDA and aPDA PS is given and stopped when the pressure is equal between bPDA and aPDA. the pressure is measured using ultrasound	Drug: PS is stopped when the pressure is equal between bPDA and aPDA. PS is given and stopped when the pressure is equal between bPDA and aPDA. the pressure is measured using ultrasound
Active Comparator: PS is given according to the 2019 European RDS management guideline PS is given according to the 2019 European RDS management guideline	Drug: PS is given according to the 2019 European RDS management guideline PS is given according to the 2019 European RDS management guideline

Arm

Intervention/Treatment

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

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

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

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

Active Comparator: PS is given according to the 2019 European RDS management guideline

PS is given according to the 2019 European RDS management guideline

Drug: PS is given according to the 2019 European RDS management guideline

PS is given according to the 2019 European RDS management guideline

Outcome Measures

Primary Outcome Measures

the size of PDA [within 7 days after birth]
the size of PDA is zero
BPD and/or death [at 36 week's gestational age]
the BPD and/or death is diagnosed when the included infants remain needing oxygen at 36 week's gestational age

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Minute to 12 Hours

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Chongqing Medical University	Chongqing		China

Sponsors and Collaborators

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Children's Hospital of Chongqing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chen Long,MD, Director, Children's Hospital of Chongqing Medical University

ClinicalTrials.gov Identifier:

NCT04984057

Other Study ID Numbers:

Surfactant dose

First Posted:

Jul 30, 2021

Last Update Posted:

Aug 20, 2021

Last Verified:

Aug 1, 2021

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.:

Additional relevant MeSH terms:

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Bronchopulmonary Dysplasia

Premature Birth

Ductus Arteriosus, Patent

Syndrome

Study Results

No Results Posted as of Aug 20, 2021