Clinical trial NCT04126382: LISA vs INSURE in the Treatment of Respiratory Distress Syndrome in Preterm Infants
Official title: The Efficacy of LISA Technology With Noninvasive Ventilation in the Treatment of Respiratory Distress Syndrome in Preterm Neonates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Preterm Infants
Keywords: NRDS
preterm infants
LISA
INSURE
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
Collaborators: name: The First Affiliated Hospital of University of Science and Technology of China
name: The First Affiliated Hospital of Bengbu Medical University
name: Second Affiliated Hospital of Bengbu Medical College
name: Fuyang people's hospital
name: lixin people's hospital
name: The Third People's Hospital of Bengbu
name: Huaibei coal general hospital
name: Bozhou people's hospital
name: Luan people's hospital
name: Huaibei maternal and child health hospital
name: Huainan maternal and child health hospital
name: Chizhou people's hospital
name: Xuancheng people's hospital
name: First Affiliated Hospital of Wannan Medical College
name: Tongling People's Hospital
name: Maanshan maternity and child care
name: Wuhu first people's hospital
name: Anqing Municipal Hospital
First posted: 2019-10-15
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of intubation
timeFrame: during the first 3 days after birth
measure: The incidence of bronchopulmonary dysplasia
timeFrame: at a post-menstrual age of 36 weeks or at discharge
Secondary outcomes:
measure: Effect on of arterial blood gas analysis
timeFrame: during the whole procedure of surfactant replacement,up to 3 days after birth
measure: The Incidence of Patent ductus arteriosus
timeFrame: during hospitalization, up to 60 days
measure: The Incidence of Pneumothorax
timeFrame: during non-invasive ventilation, up to 30 days
measure: The Incidence of Abdominal Distention
timeFrame: during non-invasive ventilation, up to 30 days
measure: The Incidence of Neonatal Necrotizing Enterocolitis(>Stage II)
timeFrame: during hospitalization, up to 60 days
measure: The Incidence of Retinopathy of Prematurity( ≥ Stage II)
timeFrame: at a post-menstrual age of 36 weeks or at discharge
measure: The Incidence of Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ)
timeFrame: during hospitalization, up to 60 days
measure: The Incidence of Periventricular Leukomalacia
timeFrame: during hospitalization, up to 36 months
measure: Predischarge Mortality
timeFrame: during hospitalization, up to 60 days
measure: The Time of Non-invasive Ventilation
timeFrame: during hospitalization, up to 60 days
measure: Days on supplemental oxygen
timeFrame: during hospitalization, up to 60 days
measure: Length of Hospitalization
timeFrame: during hospitalization, up to 60 days
Other outcomes:
Locations:
Study officials:
affiliation: Director of pediatric department of the First Affiliated Hospital of University of Science and Technology of China
name: Pan jiahua, PhD
role: STUDY_DIRECTOR
References: