A Phase 2 interventional study of Intubate-Surfactant-Extubate(INSURE) and less invasive surfactant administration(LISA) in Preterm Infants, sponsored by Anhui Provincial Hospital. Status unknown. Open to participants aged 25 Weeks to 32 Weeks. Per ClinicalTrials.gov, last updated 2019-10-15.
Sponsored by Anhui Provincial Hospital · Phase 2, Interventional, and Treatment
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.
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.
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This study's planned enrollment of 200 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
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Exclusion Criteria:
Intubate-Surfactant-Extubate(INSURE) technique is a Important treatment in premature infants with RDS.
Procedure: Intubate-Surfactant-Extubate(INSURE)
Less invasive surfactant administration(LISA) technique is a Important treatment in premature infants with RDS.
Procedure: less invasive surfactant administration(LISA)
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.
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
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).
Time frame: during the first 3 days after birth
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.
Time frame: at a post-menstrual age of 36 weeks or at discharge
Effect on of arterial blood gas analysis
The improvement of PaO2 and PaCO2 in two groups children with LISA technique
Time frame: during the whole procedure of surfactant replacement,up to 3 days after birth
The Incidence of Patent ductus arteriosus
PDA was diagnosed based on echocardiography
Time frame: during hospitalization, up to 60 days
The Incidence of Pneumothorax
Pneumothorax was diagnosed based on clinical manifestations and features of chest x-ray
Time frame: during non-invasive ventilation, up to 30 days
The Incidence of Abdominal Distention
Abdominal circumference was measured 3 times a day during non-invasive ventilation
Time frame: during non-invasive ventilation, up to 30 days
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
Time frame: during hospitalization, up to 60 days
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.
Time frame: at a post-menstrual age of 36 weeks or at discharge
The Incidence of Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ)
The criteria for intraventricular hemorrhage (IVH, ≥ grade Ⅲ): intraventricular hemorrhage with ventricular dilatation and intraventricular hemorrhage with paren-ehymal hemorrhage.
Time frame: during hospitalization, up to 60 days
The Incidence of Periventricular Leukomalacia
Periventricular Leukomalacia was diagnosed based on cranial MRI
Time frame: during hospitalization, up to 36 months
Predischarge Mortality
Time frame: during hospitalization, up to 60 days
The Time of Non-invasive Ventilation
Hours
Time frame: during hospitalization, up to 60 days
Days on supplemental oxygen
Days
Time frame: during hospitalization, up to 60 days
Length of Hospitalization
Days
Time frame: during hospitalization, up to 60 days
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
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Respiratory Distress Syndrome→
Anhui Provincial Hospital