Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS)

NCT03217162 | Unknown DMC

• 1 other identifier: surfactant for ARDS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of surfactant is not clear. This study aimed to determine whether ARDS neonate would benefit from surfactant when oxygenation deteriorated on mechanical ventilation and to identify any potential risk factors related to mortality.

Conditions

ARDS; RDS; Surfactant

Outcome Measures

Primary Outcomes (3)

• death

  neonates died

  at 36 weeks' gestational age or before discharge from hospital

• bronchopulmonary dysplasia(BPD)

  neonates were diagnosed with BPD

  at 36 weeks' gestational age or before discharge from hospital

• BPD and/or death

  neonates were diagnosed with BPD and/or death

  at 36 weeks' gestational age or before discharge from hospital

Secondary Outcomes (5)

• Bayley Scales of Infant Development

  at 2 months old and 2 years old

• haemodynamically significant patent ductusarteriosus (hsPDA)

  at 36 weeks' gestational age or before discharge from hospital

• retinopathy of prematurity (ROP)> 2nd stages

  at 36 weeks' gestational age or before discharge from hospital

• necrotizing enterocolitis (NEC) ≥ 2nd stages

  at 36 weeks' gestational age or before discharge from hospital

• intraventricular hemorrhage(IVH)>2nd grades

  at 36 weeks' gestational age or before discharge from hospital

Study Arms (2)

surfactant combined with mechanical ventilation

EXPERIMENTAL

surfactant is given to the infant with ARDS.

Drug: surfactant combined with mechanical ventilation (MV)

mechanical ventilation

ACTIVE COMPARATOR

mechanical ventilation is given to the infant with ARDS.

Drug: mechanical ventilation (MV)

Interventions

surfactant combined with mechanical ventilation (MV) DRUG

surfactant combined with mechanical ventilation (MV) is given to the infant with ARDS

surfactant combined with mechanical ventilation

mechanical ventilation (MV) DRUG

mechanical ventilation (MV) is given to the infant with ARDS

mechanical ventilation

Eligibility Criteria

• Age: 30 Minutes - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• infant less than 28 days
• diagnosis of ARDS or RDS or both
• informed parental consent has been obtained

You may not qualify if:

• major congenital malformations or complex congenital heart disease or chromosomal abnormalities
• transferred out of the neonatal intensive care unit without treatment
• upper respiratory tract abnormalities

Sponsors & Collaborators

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

Study Sites (1)

Department of neonatology, Children's hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

MeSH Terms

Interventions

Respiration, Artificial

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Shi Yuan, PhD,MD

  Children's Hospital of Chongqing Medical University

  STUDY DIRECTOR

Central Study Contacts

Ma Juan, MD

CONTACT

13883559467; 476679422@qq.com

Ma Juan, MD

CONTACT

1388.559467; 476679422@qq.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: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 13, 2017
• Study Start: August 1, 2017
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: October 25, 2022

Record last verified: 2022-10

Locations

CN (1)