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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COMPLETED
NA
237 participants
INTERVENTIONAL
2017-07-01
2019-03-30
Brief Summary
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DESIGN, SETTING, AND PARTICIPANTS The Minimal Invasive Surfactant Administration (MISA) was a multicenter, randomized, clinical, parallel-group study conducted between July 1st, 2017, and November 30, 2018, in 8 level III neonatal intensive care units in Beijing, Tianjin, and Hebei province, China. The final follow-up date was March 30, 2019. Participants enrolled spontaneously breathing preterm infants born between 26.1 and 31.9 weeks' gestational age with signs of respiratory distress syndrome. In an intention-to-treat design, infants were randomly assigned to receive surfactant (Calf pulmonary surfactant, Double-Crane Pharmaceutical Co., China) either via a 5Fr nasogastric tube during CPAP/NIPPV-assisted spontaneous breathing (minimal invasive surfactant administration group, MISA group) or after conventional endotracheal intubation during mechanical ventilation (endotracheal intubation surfactant administration group, EISA group).
INTERVENTION MISA via a 5Fr nasogastric tube with an ophthalmic surgery straight forceps.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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MISA group
minimal invasive surfactant administration group
Minimal Invasive surfactant administration
Participants enrolled spontaneously breathing preterm infants born between 26.1 and 31.9 weeks' gestational age with signs of respiratory distress syndrome. Preterm infants of the MISA (Minimal invasive surfactant administration) group were assigned to receive surfactant (Calf pulmonary surfactant, Double-Crane Pharmaceutical Co., China) via a 5Fr nasogastric tube with an ophthalmic surgery straight forceps during CPAP/NIPPV-assisted spontaneous breathing.
EISA group
conventional treatment: endotracheal intubation surfactant administration group
No interventions assigned to this group
Interventions
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Minimal Invasive surfactant administration
Participants enrolled spontaneously breathing preterm infants born between 26.1 and 31.9 weeks' gestational age with signs of respiratory distress syndrome. Preterm infants of the MISA (Minimal invasive surfactant administration) group were assigned to receive surfactant (Calf pulmonary surfactant, Double-Crane Pharmaceutical Co., China) via a 5Fr nasogastric tube with an ophthalmic surgery straight forceps during CPAP/NIPPV-assisted spontaneous breathing.
Eligibility Criteria
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Inclusion Criteria
2. spontaneously breathing receiving continuous positive airway pressure (CPAP) or NIPPV (Non-invasive positive pressure ventilation) without intubation
3. clinical diagnosis of respiratory distress syndrome.
Exclusion Criteria
2. with asphyxia requiring intubation during resuscitation
3. need endotracheal intubation or mechanical ventilation before surfactant administration.
1 Hour
4 Months
ALL
No
Sponsors
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Peking University Third Hospital
OTHER
Responsible Party
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Han Tongyan
Vice Director of Pediatrics Department, Principal Investigator, Clinical Associated Professor
Principal Investigators
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Xiaomei Tong, Master
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Locations
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Peking University Third Hospital
Beijing, , China
Countries
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Other Identifiers
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M2017160
Identifier Type: -
Identifier Source: org_study_id
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