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

Preterm Infants Clinical Trial

Official title:

The Efficacy of LISA Technology With Noninvasive Ventilation in the Treatment of Respiratory Distress Syndrome in Preterm Neonates

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04126382
• Other study ID #: LISA2020
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2019
• Source: Anhui Provincial Hospital
• Contact: Zhang Lan, PhD
• Phone: 18256935186
• Email: moaana[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Weeks to 32 Weeks

Eligibility

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 ?), and Congenital genetic metabolic disease

• transferred out of the NICUs(neonatal intensive care units) with surgical treatment or other intervention

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infants
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Procedure:
• Intubate-Surfactant-Extubate(INSURE)
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)
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.

Locations

Country	Name	City	State
n/a

Sponsors (19)

Lead Sponsor

Collaborator

Anhui Provincial Hospital

Anqing Municipal Hospital, Bengbu medical college second affiliated hospital, Bozhou people's hospital, Chizhou people's hospital, First Affiliated Hospital Bengbu Medical College, Fuyang people's hospital, Huaibei coal general hospital, Huaibei maternal and child health hospital, Huainan maternal and child health hospital, lixin people's hospital, Luan people's hospital, Maanshan maternity and child care, The affiliated hospital of wannan medical college, the First Affiliated Hospital of University of Science and Technology of China, The third people's hospital of bengbu, Tongling People's Hospital, Wuhu first people's hospital, Xuancheng people's hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of intubation	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).	during the first 3 days after birth
Primary	The incidence of bronchopulmonary dysplasia	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.	at a post-menstrual age of 36 weeks or at discharge
Secondary	Effect on of arterial blood gas analysis	The improvement of PaO2 and PaCO2 in two groups children with LISA technique	during the whole procedure of surfactant replacement,up to 3 days after birth
Secondary	The Incidence of Patent ductus arteriosus	PDA was diagnosed based on echocardiography	during hospitalization, up to 60 days
Secondary	The Incidence of Pneumothorax	Pneumothorax was diagnosed based on clinical manifestations and features of chest x-ray	during non-invasive ventilation, up to 30 days
Secondary	The Incidence of Abdominal Distention	Abdominal circumference was measured 3 times a day during non-invasive ventilation	during non-invasive ventilation, up to 30 days
Secondary	The Incidence of Neonatal Necrotizing Enterocolitis(>Stage II)	Neonatal Necrotizing Enterocolitis was diagnosed by clinical manifestations and features of abdominal x-Ray based on the Practical neonatology 4th edition	during hospitalization, up to 60 days
Secondary	The Incidence of Retinopathy of Prematurity( = Stage II)	The criteria for Retinopathy of prematurity (>Stage II); extraretinal fibrovascular proliferation neovascularization extends from ridge into the vitreous.	at a post-menstrual age of 36 weeks or at discharge
Secondary	The Incidence of Intraventricular Hemorrhage (IVH, = Grade ?)	The criteria for intraventricular hemorrhage (IVH, = grade ?): intraventricular hemorrhage with ventricular dilatation and intraventricular hemorrhage with paren-ehymal hemorrhage.	during hospitalization, up to 60 days
Secondary	The Incidence of Periventricular Leukomalacia	Periventricular Leukomalacia was diagnosed based on cranial MRI	during hospitalization, up to 36 months
Secondary	Predischarge Mortality		during hospitalization, up to 60 days
Secondary	The Time of Non-invasive Ventilation	Hours	during hospitalization, up to 60 days
Secondary	Days on supplemental oxygen	Days	during hospitalization, up to 60 days
Secondary	Length of Hospitalization	Days	during hospitalization, up to 60 days