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

NCT ID: NCT03385863

Last Updated: 2017-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2018-03-01

Brief Summary

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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

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Conditions

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Infant, Newborn, NRDS

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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early preterm infants with RDS

gestational age\<34 weeks

Surfactant, Pulmonary，Curosurf

Intervention Type DRUG

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.

Perinatal risk factors of NRDS

Intervention Type OTHER

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

Surfactant, Pulmonary，Curosurf

Intervention Type DRUG

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.

Perinatal risk factors of NRDS

Intervention Type OTHER

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

Surfactant, Pulmonary，Curosurf

Intervention Type DRUG

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.

Perinatal risk factors of NRDS

Intervention Type OTHER

Compare the perinatal risk factors that were closely related to NRDS between early preterm infants with RDS and near term/term infants with RDS.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Hour

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Li Wang

Daping Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Daping Hospital, Third Military Medical University

Locations

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Department of pediatrics, Daping Hospital, The Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Wang, Doctor

Role: CONTACT

Phone: 008613527499258

Email: [email protected]

Yuan Shi, Doctor

Role: CONTACT

Email: [email protected]

Facility Contacts

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Li Wang, MD

Role: primary

Other Identifiers

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02333669

Identifier Type: -

Identifier Source: org_study_id