Bronchopulmonary Dysplasia Clinical Trial
Official title:
Minimal Invasive Surfactant Administration to Treat Neonatal Respiratory Distress Syndrome: a Multicenter Clinical Study in China
NCT number | NCT04077333 |
Other study ID # | M2017160 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2017 |
Est. completion date | March 30, 2019 |
Verified date | September 2019 |
Source | Peking University Third Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
BACKGROUND Treatment of neonatal respiratory distress syndrome with exogenous surfactant and
mechanical ventilation made millions of preterm infants survived in neonatal intensive care
unit (NICU). Endotracheal intubation surfactant administration is related to invasive
intubation and short periods of positive pressure ventilation and implies the risk of lung
injury. Continuous positive airway pressure (CPAP) or NIPPV (Non-invasive positive pressure
ventilation) with surfactant but without intubation may work synergistically. This randomized
trial investigated a minimal invasive surfactant administration (MISA). To test the
hypothesis that MISA increases survival without bronchopulmonary dysplasia (BPD) at 36 weeks'
gestational age in very low birth weight infants.
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.
Status | Completed |
Enrollment | 237 |
Est. completion date | March 30, 2019 |
Est. primary completion date | November 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 4 Months |
Eligibility |
Inclusion Criteria: 1. preterm infants born before 32 weeks gestational age 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: 1. with obvious malformations 2. with asphyxia requiring intubation during resuscitation 3. need endotracheal intubation or mechanical ventilation before surfactant administration. |
Country | Name | City | State |
---|---|---|---|
China | Peking University Third Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University Third Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of bronchopulmonary dysplasia (BPD) | Number of very low birth weight preterm infants with BPD | At 36 weeks'gestational age | |
Secondary | Incidence of major complications | Number of very low birth weight preterm infants diagnosed with major complications (i.e.patent ductus arteriosus,pulmonary hemorrhage, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, and retinopathy of prematurity) | Through study completion and up to corrected three months |
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