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

A

Army Medical University of People's Liberation Army

Status

Unknown

Conditions

Infant, Newborn, NRDS

Treatments

Other: Perinatal risk factors of NRDS
Drug: Surfactant, Pulmonary,Curosurf

Study type

Observational

Funder types

Other

Identifiers

NCT03385863
02333669

Details and patient eligibility

About

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.

Enrollment

1,500 estimated patients

Sex

All

Ages

1 hour to 28 days old

Volunteers

No Healthy Volunteers

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.

Trial design

1,500 participants in 3 patient groups

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

Trial contacts and locations

1

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Central trial contact

Li Wang, Doctor; Yuan Shi, Doctor

Data sourced from clinicaltrials.gov

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