NCT04077333

MISA to NRDS：a Multicenter Study in China

Completed NA Last updated 6 September 2019

What this trial tests

NA trial testing Minimal Invasive surfactant administration in Bronchopulmonary Dysplasia in 237 participants. Completed in 30 March 2019.

Timeline

1 July 2017

Primary endpoint
30 November 2018

30 March 2019

Quick facts

Lead sponsor	Peking University Third Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	237
Start date	1 July 2017
Primary completion	30 November 2018
Estimated completion	30 March 2019
Sites	1 location across China

Drugs / interventions tested

• Minimal Invasive surfactant administration

Conditions studied

• Bronchopulmonary Dysplasia — all drugs for Bronchopulmonary Dysplasia →
• Patent Ductus Arteriosus — all drugs for Patent Ductus Arteriosus →
• Intraventricular Hemorrhage — all drugs for Intraventricular Hemorrhage →
• Necrotizing Enterocolitis — all drugs for Necrotizing Enterocolitis →

Sponsor

Peking University Third Hospital

Who can join

Adults 1 Hour to 4 Months, any sex, with Bronchopulmonary Dysplasia or Patent Ductus Arteriosus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Surfactant therapy via thin catheter in preterm infants with or at risk of respiratory distress syndrome.
   Abdel-Latif ME, Davis PG, Wheeler KI, De Paoli AG, et al · · 2021 · cited 100× · PMID 33970483 · DOI 10.1002/14651858.cd011672.pub2
2. Minimally Invasive Surfactant Administration for the Treatment of Neonatal Respiratory Distress Syndrome: A Multicenter Randomized Study in China.
   Han T, Liu H, Zhang H, Guo M, et al · · 2020 · cited 24× · PMID 32457854 · DOI 10.3389/fped.2020.00182
3. [Risk factors for minimally invasive surfactant administration failure in preterm infants with respiratory distress syndrome].
   Liu HQ, Tong XM, Han TY, Zhang H, et al · · 2020 · cited 1× · PMID 32204759 · DOI 10.7499/j.issn.1008-8830.2020.03.010