LISA vs INSURE in the Treatment of Respiratory Distress Syndrome in Preterm Infants

University of Science and Technology of China (USTC)

Status and phase: Not yet enrolling; Phase 2

Conditions: Preterm Infants

Treatments: Procedure: Intubate-Surfactant-Extubate(INSURE); Procedure: less invasive surfactant administration(LISA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04126382

LISA2020

Details and patient eligibility

About

To evaluate the efficacy of less invasive surfactant administration（LISA ）technique in the treatment of neonatal respiratory distress syndrome（NRDS） by comparing with the traditional Intubate-Surfactant-Extubate（INSURE） technique.

Full description

Background: Neonatal Respiratory distress syndrome (NRDS) is the most common cause of respiratory problems in premature babies. Surfactant administration involved with endotracheal intubation and mechanical ventilation has proven to be a effective treatment, however, it is associated with a risk of barotrauma, volutrauma and bronchopulmonary dysplasia(BPD). In recent years, some studies have demonstrated that prophylactic INSURE did not lead to a higher survival without BPD, and LISA technique is recommended. However there is no multicenter and Large sample research about it. The aim of this multicenter trial is to compare the efficacy between LISA-treated and INSURE-treated premature Preterm babies with respiratory distress syndrome(RDS).

Methods/Design：In this multicenter, randomized, cohort, prospective trial, 200 preterm infants from 18 neonatal intensive care units in AnHui province whose gestational age (GA) less than 32 weeks with a diagnosis of RDS will be randomized to LISA-treated group and INSURE-treated group.

The primary outcomes include rate of intubation,incidence of bronchopulmonary dysplasia(BPD).The secondary outcomes include arterial blood gas analysis,severity of RDS,the incidence of Patent ductus arteriosus(PDA),Pneumothorax,Abdominal Distention,Neonatal Necrotizing Enterocolitis(NEC,>Stage II), Retinopathy of Prematurity( ROP,≥ Stage II), Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ), Periventricular Leukomalacia(PVL) , mortality, days on noninvasive respiratory support,days on supplemental oxygen and days of hospitalization.Other secondary outcomes include scores of Gesell development Scales of infant development at 3 years of corrected age.

Enrollment: 200 estimated patients

Sex: All

Ages: 25 to 32 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestational age (GA) less than 32 weeks
• diagnosis of RDS. The diagnosis of RDS will be based on clinical manifestations (Progressive dyspnea, nasal flaring and or grunting), chest X-ray findings and need for noninvasive ventilation support(fraction of inspired oxygen>40％) in 6 hours after birth
• informed parental consent has been obtained

Exclusion criteria

• severe RDS have been treated with endotracheal intubation,surfactant and mechanical ventilation
• major congenital malformations or complex congenital heart disease
• Pulmonary hemorrhage
• Cardiopulmonary failure
• septicemia, Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ), and Congenital genetic metabolic disease
• transferred out of the NICUs(neonatal intensive care units) with surgical treatment or other intervention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

INSURE

Active Comparator group

Description:

Intubate-Surfactant-Extubate(INSURE) technique is a Important treatment in premature infants with RDS.

Treatment:

Procedure: Intubate-Surfactant-Extubate(INSURE)

LISA

Experimental group

Description:

Less invasive surfactant administration(LISA) technique is a Important treatment in premature infants with RDS.

Treatment:

Procedure: less invasive surfactant administration(LISA)