Preterm Infants
Conditions
Keywords
NRDS, preterm infants, LISA, INSURE
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.
Interventions
PROCEDUREIntubate-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.
PROCEDUREless 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.
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
The First Affiliated Hospital of Bengbu Medical University
Second Affiliated Hospital of Bengbu Medical College
Fuyang people's hospital
lixin people's hospital
The Third People's Hospital of Bengbu
Huaibei coal general hospital
Bozhou people's hospital
Luan people's hospital
Huaibei maternal and child health hospital
Huainan maternal and child health hospital
Chizhou people's hospital
Xuancheng people's hospital
First Affiliated Hospital of Wannan Medical College
Tongling People's Hospital
Maanshan maternity and child care
Wuhu first people's hospital
Anqing Municipal Hospital
Anhui Provincial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Weeks to 32 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| Predischarge Mortality | during hospitalization, up to 60 days | — |
| 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 |
| The Incidence of Periventricular Leukomalacia | during hospitalization, up to 36 months | Periventricular Leukomalacia was diagnosed based on cranial MRI |
| The Incidence of Patent ductus arteriosus | during hospitalization, up to 60 days | PDA was diagnosed based on echocardiography |
Contacts
Primary ContactZhang Lan, PhD
Backup ContactPan Jiahua, PhD
Outcome results
None listed