NCT03989960

Modified Intubation-surfactant-extubation (InSurE) Technique in Preterm Neonates With Respiratory Distress Syndrome

Status unknown NA Last updated 21 June 2019

What this trial tests

NA trial testing LISA+SNIPPV in Respiratory Distress Syndrome of Newborn in 120 participants. Status unknown.

Timeline

1 August 2018

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	The First Affiliated Hospital with Nanjing Medical University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	120
Start date	1 August 2018
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	1 location across China

Drugs / interventions tested

• LISA+SNIPPV
• traditional InSurE

Conditions studied

• Respiratory Distress Syndrome of Newborn — all drugs for Respiratory Distress Syndrome of Newborn →

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Who can join

Under 1, any sex, with Respiratory Distress Syndrome of Newborn. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study evaluates the less invasive surfactant administration (LISA) combined with synchronized nasal intermittent positive pressure ventilation (SNIPPV) technique in the treatment of respiratory distress syndrome (RDS) of preterm neonates. The modified InSurE group will receive "LISA + SNIPPV" technique, while the traditional InSurE group will receive the intubation, surfactant, extubation and CPAP technique.

Publications & conference data

2 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. A clinical study evaluating the combination of LISA and SNIPPV for the treatment of respiratory distress syndrome in preterm infants.
   Permall DL, Zhang Y, Li H, Guan Y, et al · · 2024 · cited 2× · PMID 38228632 · DOI 10.1038/s41598-023-50303-0