Preterm Infants Clinical Trial
Official title:
The Efficacy of LISA Technology With Noninvasive Ventilation in the Treatment of Respiratory Distress Syndrome in Preterm Neonates
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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