Efficacy of Surfactant and Perinatal Risk Factors in NRDS With Different Gestational Ages

• Conditions: Infant, Newborn, NRDS
• Interventions: Drug: Surfactant, Pulmonary，Curosurf; Other: Perinatal risk factors of NRDS

• Registration Number: NCT03385863
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Brief Summary

Since exogenous surfactant replacement therapy was first used to prevent neonatal respiratory distress syndrome (NRDS)，it has become the main method of treatment of NRDS. However, in some infants, death is inevitable despite intensive care and surfactant replacement therapy, especially in near-term and term infants. The first goal of our study is to compare the therapeutic effect of pulmonary surfactant of infants at different gestational ages and to investigate whether exogenous surfactant replacement therapy is effective for all newborns with RDS. The second goal of our study is to further analyze the risk factors and causes of RDS in early preterm infants and near term/term infants.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2016-12-30
• Status Verified: 2017-12
• Study First Submitted: 2017-12-21
• Study First Submitted QC: 2017-12-21
• Last Update Submitted: 2017-12-21
• Study First Posted: 2017-12-29
• Last Update Posted: 2017-12-29
• Study Completion: 2018-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Infants with RDS who received surfactant therapy were recruited between January 2011 and December 2016.

Exclusion Criteria

Infants were excluded if they had any congeni- tal malformation, inherited metabolic abnormality, intrauterine infection, Rh/Rh incompatibility, pneumonia, pulmonary hypertension, meconium aspiration syndrome, or asphyxia.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
early preterm infants with RDS	Surfactant, Pulmonary，Curosurf	gestational age\<34 weeks
term infants with RDS	Surfactant, Pulmonary，Curosurf	Gestational age ≥ 37 weeks
near term infants with RDS	Perinatal risk factors of NRDS	34 weeks≤gestational age\< 37 weeks
early preterm infants with RDS	Perinatal risk factors of NRDS	gestational age\<34 weeks
near term infants with RDS	Surfactant, Pulmonary，Curosurf	34 weeks≤gestational age\< 37 weeks
term infants with RDS	Perinatal risk factors of NRDS	Gestational age ≥ 37 weeks

Primary Outcome Measures

Name	Time	Method
therapeutic effect of pulmonary surfactant of infants at different gestational ages	January 1，2011 to December 30，2016

Trial Locations

Locations (1)

Department of pediatrics, Daping Hospital, The Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China