MISA to NRDS：a Multicenter Study in China

Not Applicable

Completed

• Conditions: Intraventricular Hemorrhage; Periventricular Leukomalacia; Bronchopulmonary Dysplasia; Patent Ductus Arteriosus; Necrotizing Enterocolitis
• Interventions: Procedure: Minimal Invasive surfactant administration

• Registration Number: NCT04077333
• Lead Sponsor: Peking University Third Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2018-11-30
• Study Completion: 2019-03-30
• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-08-31
• Status Verified: 2019-09
• Study First Posted: 2019-09-04
• Last Update Submitted: 2019-09-04
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MISA group	Minimal Invasive surfactant administration	minimal invasive surfactant administration group

Primary Outcome Measures

Name	Time	Method
Incidence of bronchopulmonary dysplasia (BPD)	At 36 weeks'gestational age	Number of very low birth weight preterm infants with BPD

Secondary Outcome Measures

Name	Time	Method
Incidence of major complications	Through study completion and up to corrected three months	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）

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China