MISA to NRDS：a Multicenter Study in China

NCT04077333 | Completed

• 1 other identifier: M2017160
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bronchopulmonary Dysplasia; Patent Ductus Arteriosus; Intraventricular Hemorrhage; Necrotizing Enterocolitis; Periventricular Leukomalacia

Outcome Measures

Primary Outcomes (1)

• Incidence of bronchopulmonary dysplasia (BPD)

  Number of very low birth weight preterm infants with BPD

  At 36 weeks'gestational age

Secondary Outcomes (1)

• Incidence of major complications

  Through study completion and up to corrected three months

Study Arms (2)

MISA group

EXPERIMENTAL

minimal invasive surfactant administration group

Procedure: Minimal Invasive surfactant administration

EISA group

NO INTERVENTION

conventional treatment: endotracheal intubation surfactant administration group

Interventions

Minimal Invasive surfactant administration PROCEDURE

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.

MISA group

Eligibility Criteria

• Age: 1 Hour - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• preterm infants born before 32 weeks gestational age
• spontaneously breathing receiving continuous positive airway pressure (CPAP) or NIPPV (Non-invasive positive pressure ventilation) without intubation
• clinical diagnosis of respiratory distress syndrome.

You may not qualify if:

• with obvious malformations
• with asphyxia requiring intubation during resuscitation
• need endotracheal intubation or mechanical ventilation before surfactant administration.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Ductus Arteriosus, Patent; Enterocolitis, Necrotizing; Leukomalacia, Periventricular

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Encephalomalacia; Vascular Diseases

Study Officials

• Xiaomei Tong, Master

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of Pediatrics Department, Principal Investigator, Clinical Associated Professor

Model Details: A randomized, clinical, parallel-group study

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: September 4, 2019
• Study Start: July 1, 2017
• Primary Completion: November 30, 2018
• Study Completion: March 30, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)