Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The First Affiliated Hospital of University of Science and Technology of China | OTHER |
| The First Affiliated Hospital of Bengbu Medical University | OTHER |
| Second Affiliated Hospital of Bengbu Medical College |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INSURE | Active Comparator | Intubate-Surfactant-Extubate(INSURE) technique is a Important treatment in premature infants with RDS. |
|
| LISA | Experimental | Less invasive surfactant administration(LISA) technique is a Important treatment in premature infants with RDS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intubate-Surfactant-Extubate(INSURE) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The Incidence of Patent ductus arteriosus |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhang Lan, PhD | Contact | 18256935186 | moaana@163.com | |
| Pan Jiahua, PhD | Contact | 13866167758 | panjiahua1960@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Pan jiahua, PhD | Director of pediatric department of the First Affiliated Hospital of University of Science and Technology of China | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fuyang people's hospital | OTHER |
| lixin people's hospital | UNKNOWN |
| The Third People's Hospital of Bengbu | OTHER_GOV |
| Huaibei coal general hospital | UNKNOWN |
| Bozhou people's hospital | UNKNOWN |
| Luan people's hospital | UNKNOWN |
| Huaibei maternal and child health hospital | UNKNOWN |
| Huainan maternal and child health hospital | UNKNOWN |
| Chizhou people's hospital | UNKNOWN |
| Xuancheng People's Hospital | OTHER |
| First Affiliated Hospital of Wannan Medical College | OTHER |
| Tongling People's Hospital | OTHER_GOV |
| Maanshan maternity and child care | UNKNOWN |
| Wuhu first people's hospital | UNKNOWN |
| Anqing Municipal Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| less invasive surfactant administration(LISA) | Procedure | 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. |
|
PDA was diagnosed based on echocardiography
| during hospitalization, up to 60 days |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. | during hospitalization, up to 60 days |
| The Incidence of Periventricular Leukomalacia | Periventricular Leukomalacia was diagnosed based on cranial MRI | during hospitalization, up to 36 months |
| Predischarge Mortality | during hospitalization, up to 60 days |
| The Time of Non-invasive Ventilation | Hours | during hospitalization, up to 60 days |
| Days on supplemental oxygen | Days | during hospitalization, up to 60 days |
| Length of Hospitalization | Days | during hospitalization, up to 60 days |