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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03385863
Enrollment
1500
Registered
2017-12-29
Start date
2011-01-01
Completion date
2018-03-01
Last updated
2017-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Newborn, NRDS

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.

Interventions

DRUGSurfactant, 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.

OTHERPerinatal 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.

Sponsors

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Hours to 28 Days
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
therapeutic effect of pulmonary surfactant of infants at different gestational agesJanuary 1,2011 to December 30,2016

Countries

China

Contacts

Primary ContactLi Wang, Doctor
liwang8771@126.com008613527499258
Backup ContactYuan Shi, Doctor
13527499258@163.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026