MISA to NRDS：a Multicenter Study in China

Bronchopulmonary Dysplasia Clinical Trial

Official title:

Minimal Invasive Surfactant Administration to Treat Neonatal Respiratory Distress Syndrome: a Multicenter Clinical Study in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04077333
• Other study ID #: M2017160
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: March 30, 2019

Study information

• Verified date: September 2019
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Ductus Arteriosus, Patent
• Enterocolitis
• Enterocolitis, Necrotizing
• Hemorrhage
• Intraventricular Hemorrhage
• Leukomalacia, Periventricular
• Necrotizing Enterocolitis
• Patent Ductus Arteriosus
• Periventricular Leukomalacia

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

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