Modified Intubation-surfactant-extubation (InSurE) Technique in Preterm Neonates With Respiratory Distress Syndrome

The First Affiliated Hospital with Nanjing Medical University120 enrolled

Overview

This study evaluates the less invasive surfactant administration (LISA) combined with synchronized nasal intermittent positive pressure ventilation (SNIPPV) technique in the treatment of respiratory distress syndrome (RDS) of preterm neonates. The modified InSurE group will receive "LISA + SNIPPV" technique, while the traditional InSurE group will receive the intubation, surfactant, extubation and CPAP technique.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Respiratory Distress Syndrome of Newborn

Interventions

LISA+SNIPPVPROCEDURE

The LISA+SNIPPV group receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation.

traditional InSurEPROCEDURE

The traditional InSurE group receives intubation-surfactant- extubation technique and selects CPAP ventilation.

Eligibility

Sex: ALLMax age: 1 Year

Medical Language ↔ Plain English

Inclusion Criteria: 1. premature infants with birth weight \< 2500g and gestational age \< 36+6 weeks; 2. High-risk premature infants with early symptoms of RDS or infants who are diagnosed clinically RDS. 3. the participating hospital obtained the consent of the Ethics Committee. 4. parental informed consents were obtained. Exclusion Criteria: 1. severe congenital malformations. 2. severe cyanotic congenital heart disease (such as transposition of great artery, tetralogy of Fallot, etc.) which affects systemic hemodynamics. 3. congenital hereditary metabolic diseases. 4. parental informed consent was not obtained.

Locations (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China

Outcomes

Primary Outcomes

the average duration of mechanical ventilation

the average duration of mechanical ventilation of each group

Time frame: 40 weeks

the duration of oxygen therapy

the duration of oxygen therapy of each group

Time frame: 40 weeks

the incidence of BPD

the incidence of BPD in each group

Time frame: 28 days

Secondary Outcomes

Pulmonary Severity Score (PSC)

PSC was defined as FiO2 × support + medications, where FiO2 is the actual or 'effective' (for nasal cannula) FiO2; support is 2.5 for a ventilator, 1.5 for nasal continuous positive airway pressure, or 1.0 for nasal cannula or hood oxygen; and medications is 0.20 for systemic steroids for BPD, 0.10 each for regular diuretics or inhaled steroids, and 0.05 each for methylxanthines or intermittent diuretics. The scores can range from 0.21 to 2.95.

Time frame: 1st, 2nd, 3rd, 7th, 14th, 28th days

the incidence of complications

the incidence of complications (e.g. necrotizing enterocolitis, cholestasis, retinopathy of prematurity, extrauterine growth retardation)

Time frame: 40 weeks

oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2)

Time frame: the period of oxygen therapy

Data from ClinicalTrials.gov

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