Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome

NCT04984057 | Unknown DMC

• 1 other identifier: Surfactant dose
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

EXPERIMENTAL

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 according to the 2019 European RDS management guideline

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

Interventions

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

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

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

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

Eligibility Criteria

• Age: 1 Minute - 12 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• main congenital abnormalities
• parents' refusal or quit

Sponsors & Collaborators

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

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Ductus Arteriosus, Patent; Bronchopulmonary Dysplasia; Premature Birth

Interventions

acetylamino propylidene diphosphonic acid

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Ventilator-Induced Lung Injury; Lung Injury; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Chen Long, PhD,MD

CONTACT

13883559467; neuroclong@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 24, 2021
• First Posted: July 30, 2021
• Study Start: August 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

CN (1)