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

A Multicenter Clinical Study on the Comparison of the Efficacy of Surfactant and Perinatal Risk Factors in NRDS With Different Gestational Ages

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.

Study Overview

• Status: Unknown
• Conditions: Infant, Newborn, NRDS
• Intervention / Treatment: Drug: Surfactant, Pulmonary，Curosurf; Other: Perinatal risk factors of NRDS

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Recruiting
      • Department of pediatrics, Daping Hospital, The Third Military Medical University
      • Contact: Li Wang, MD; Phone Number: 008613527499258; Email: liwang8771@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Infants with RDS who received surfactant therapy were recruited from 24 hospitals between January 2011 and December 2016.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
early preterm infants with RDS; gestational age<34 weeks	Drug: Surfactant, Pulmonary，Curosurf; All NRDS were given an early endotracheal infusion of Curosuf, with an initial dose of 200mg/kg, and if the condition needed to be repeated. 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.; Other: Perinatal risk factors of NRDS; Compare the perinatal risk factors that were closely related to NRDS between early preterm infants with RDS and near term/term infants with RDS.
near term infants with RDS; 34 weeks≤gestational age< 37 weeks	Drug: Surfactant, Pulmonary，Curosurf; All NRDS were given an early endotracheal infusion of Curosuf, with an initial dose of 200mg/kg, and if the condition needed to be repeated. 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.; Other: Perinatal risk factors of NRDS; Compare the perinatal risk factors that were closely related to NRDS between early preterm infants with RDS and near term/term infants with RDS.
term infants with RDS; Gestational age ≥ 37 weeks	Drug: Surfactant, Pulmonary，Curosurf; All NRDS were given an early endotracheal infusion of Curosuf, with an initial dose of 200mg/kg, and if the condition needed to be repeated. 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.; Other: Perinatal risk factors of NRDS; Compare the perinatal risk factors that were closely related to NRDS between early preterm infants with RDS and near term/term infants with RDS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
therapeutic effect of pulmonary surfactant of infants at different gestational ages	January 1，2011 to December 30，2016

Collaborators and Investigators

• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Investigators: Principal Investigator: Li Wang, Doctor, Daping Hospital, Third Military Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): December 30, 2016
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: December 21, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Actual): December 29, 2017
• Last Update Submitted That Met QC Criteria: December 21, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory System Agents; Pulmonary Surfactants; Poractant alfa
• Other Study ID Numbers: 02333669

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No