Modified Intubation-surfactant-extubation (InSurE) Technique in Preterm Neonates With Respiratory Distress Syndrome
NCT ID: NCT03989960
Last Updated: 2019-06-21
Study Results
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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UNKNOWN
NA
120 participants
INTERVENTIONAL
2018-08-01
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LISA+SNIPPV group
receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation
LISA+SNIPPV
The LISA+SNIPPV group receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation.
InSurE group
receives intubation-surfactant- extubation technique and selects CPAP ventilation
traditional InSurE
The traditional InSurE group receives intubation-surfactant- extubation technique and selects CPAP ventilation.
Interventions
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LISA+SNIPPV
The LISA+SNIPPV group receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation.
traditional InSurE
The traditional InSurE group receives intubation-surfactant- extubation technique and selects CPAP ventilation.
Eligibility Criteria
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Inclusion Criteria
2. High-risk premature infants with early symptoms of RDS or infants who are diagnosed clinically RDS.
3. the participating hospital obtained the consent of the Ethics Committee.
4. parental informed consents were obtained.
Exclusion Criteria
2. severe cyanotic congenital heart disease (such as transposition of great artery, tetralogy of Fallot, etc.) which affects systemic hemodynamics.
3. congenital hereditary metabolic diseases.
4. parental informed consent was not obtained.
1 Year
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Principal Investigators
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Xiaoqing Chen, Dr
Role: STUDY_DIRECTOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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The First Affiliated Hospital of Nanjing Medical University
Nanjing, , China
Countries
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References
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Gopel W, Kribs A, Hartel C, Avenarius S, Teig N, Groneck P, Olbertz D, Roll C, Vochem M, Weller U, von der Wense A, Wieg C, Wintgens J, Preuss M, Ziegler A, Roth B, Herting E; German Neonatal Network (GNN). Less invasive surfactant administration is associated with improved pulmonary outcomes in spontaneously breathing preterm infants. Acta Paediatr. 2015 Mar;104(3):241-6. doi: 10.1111/apa.12883.
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Wu W, Shi Y, Li F, Wen Z, Liu H. Surfactant administration via a thin endotracheal catheter during spontaneous breathing in preterm infants. Pediatr Pulmonol. 2017 Jun;52(6):844-854. doi: 10.1002/ppul.23651. Epub 2017 Feb 2.
Klotz D, Porcaro U, Fleck T, Fuchs H. European perspective on less invasive surfactant administration-a survey. Eur J Pediatr. 2017 Feb;176(2):147-154. doi: 10.1007/s00431-016-2812-9. Epub 2016 Dec 9.
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Other Identifiers
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MOLISAN
Identifier Type: -
Identifier Source: org_study_id
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