LISA vs INSURE in the Treatment of Respiratory Distress Syndrome in Preterm Infants
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|ClinicalTrials.gov Identifier: NCT04126382|
Recruitment Status : Not yet recruiting
First Posted : October 15, 2019
Last Update Posted : October 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Preterm Infants||Procedure: Intubate-Surfactant-Extubate(INSURE) Procedure: less invasive surfactant administration(LISA)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy of LISA Technology With Noninvasive Ventilation in the Treatment of Respiratory Distress Syndrome in Preterm Neonates|
|Estimated Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||December 31, 2024|
Active Comparator: INSURE
Intubate-Surfactant-Extubate(INSURE) technique is a Important treatment in premature infants with RDS.
Infants are given an endotracheal intubation, with manual lung inflation in order to keep the oxygen supply，and the surfactant(kelisu,China Resources Shuanghe Pharmaceutical) was slowly instilled into the airway through the tracheal tube, and the tracheal tube was removed for non-invasive NCPAP(nasal continuous positive airway pressure)-assisted breathing.
Less invasive surfactant administration(LISA) technique is a Important treatment in premature infants with RDS.
Procedure: less invasive surfactant administration(LISA)
Infants are spontaneously breathing with nasal CPAP(continuous positive airway pressure) support without manual lung inflation and surfactant(kelisu,China Resources Shuanghe Pharmaceutical) is administered through vocal cords via a smaller catheter.
- Rate of intubation [ Time Frame: 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).
- The incidence of bronchopulmonary dysplasia [ Time Frame: 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.
- Effect on of arterial blood gas analysis [ Time Frame: 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 Patent ductus arteriosus [ Time Frame: during hospitalization, up to 60 days ]PDA was diagnosed based on echocardiography
- The Incidence of Pneumothorax [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 Incidence of Periventricular Leukomalacia [ Time Frame: during hospitalization, up to 36 months ]Periventricular Leukomalacia was diagnosed based on cranial MRI
- Predischarge Mortality [ Time Frame: during hospitalization, up to 60 days ]
- The Time of Non-invasive Ventilation [ Time Frame: during hospitalization, up to 60 days ]Hours
- Days on supplemental oxygen [ Time Frame: during hospitalization, up to 60 days ]Days
- Length of Hospitalization [ Time Frame: during hospitalization, up to 60 days ]Days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126382
|Contact: Zhang Lan, PhDemail@example.com|
|Contact: Pan Jiahua, PhDfirstname.lastname@example.org|
|Study Director:||Pan jiahua, PhD||Director of pediatric department of the First Affiliated Hospital of University of Science and Technology of China|