LISA vs INSURE in the Treatment of Respiratory Distress Syndrome in Preterm Infants
- Conditions
- Preterm Infants
- Interventions
- Procedure: Intubate-Surfactant-Extubate(INSURE)Procedure: less invasive surfactant administration(LISA)
- Registration Number
- NCT04126382
- Lead Sponsor
- Anhui Provincial Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description INSURE Intubate-Surfactant-Extubate(INSURE) Intubate-Surfactant-Extubate(INSURE) technique is a Important treatment in premature infants with RDS. LISA less invasive surfactant administration(LISA) Less invasive surfactant administration(LISA) technique is a Important treatment in premature infants with RDS.
- Primary Outcome Measures
Name Time Method The incidence of bronchopulmonary dysplasia at a post-menstrual age of 36 weeks or at discharge BPD was diagnosed and classified based on the Practical neonatology 4th edition:Need for O2 supplementation(FiO2\>0.21) for at least 28 days after birth.
Rate of intubation during the first 3 days after birth The criteria for endotracheal mechanical ventilation were as follows: severe apnea and bradycardia (defined as recurrent apnea with \> 3 episodes per hour associated with heart rate \< 100/min, a single episode of apnea that required bag and mask ventilation), hypoxia (FiO2\>0.6 with PaO2\<50mmHg or TcSO\<0.85), severe respiratory acidosis (PaCO2 \> 60 mmHg with pH\<7.20).
- Secondary Outcome Measures
Name Time Method Effect on of arterial blood gas analysis during the whole procedure of surfactant replacement,up to 3 days after birth The improvement of PaO2 and PaCO2 in two groups children with LISA technique
The Incidence of Periventricular Leukomalacia during hospitalization, up to 36 months Periventricular Leukomalacia was diagnosed based on cranial MRI
Predischarge Mortality during hospitalization, up to 60 days The Incidence of Patent ductus arteriosus during hospitalization, up to 60 days PDA was diagnosed based on echocardiography
The Incidence of Pneumothorax during non-invasive ventilation, up to 30 days Pneumothorax was diagnosed based on clinical manifestations and features of chest x-ray
The Incidence of Abdominal Distention during non-invasive ventilation, up to 30 days Abdominal circumference was measured 3 times a day during non-invasive ventilation
The Incidence of Neonatal Necrotizing Enterocolitis(>Stage II) during hospitalization, up to 60 days Neonatal Necrotizing Enterocolitis was diagnosed by clinical manifestations and features of abdominal x-Ray based on the Practical neonatology 4th edition
The Incidence of Retinopathy of Prematurity( ≥ Stage II) at a post-menstrual age of 36 weeks or at discharge The criteria for Retinopathy of prematurity (\>Stage II); extraretinal fibrovascular proliferation neovascularization extends from ridge into the vitreous.
The Incidence of Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ) during hospitalization, up to 60 days The criteria for intraventricular hemorrhage (IVH, ≥ grade Ⅲ): intraventricular hemorrhage with ventricular dilatation and intraventricular hemorrhage with paren-ehymal hemorrhage.
The Time of Non-invasive Ventilation during hospitalization, up to 60 days Hours
Days on supplemental oxygen during hospitalization, up to 60 days Days
Length of Hospitalization during hospitalization, up to 60 days Days