Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome

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

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia; Patent Ductus Arteriosus; Preterm
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chen Long, PhD,MD; Phone Number: 86 13883559467; Email: neuroclong@126.com

Study Locations

• China
  • Chongqing, China
    • Recruiting
    • Children's Hospital of Chongqing Medical University
    • Contact: Chen Long, PhD,MD; Phone Number: 86 13883559467; Email: neuroclong@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 12 hours (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• main congenital abnormalities
• parents' refusal or quit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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	Drug: PS is given according to the 2019 European RDS management guideline; PS is given according to the 2019 European RDS management guideline

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: July 24, 2021
• First Submitted That Met QC Criteria: July 24, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Congenital Abnormalities; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Lung Injury; Heart Defects, Congenital; Cardiovascular Abnormalities; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Syndrome; Premature Birth; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia; Ductus Arteriosus, Patent
• Other Study ID Numbers: Surfactant dose

Drug and device information, study documents

• 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