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

Not Applicable

• Conditions: Respiratory Distress Syndrome of Newborn
• Interventions: Procedure: traditional InSurE; Procedure: LISA+SNIPPV

• Registration Number: NCT03989960
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Status Verified: 2019-06
• Study First Submitted: 2019-06-17
• Study First Submitted QC: 2019-06-17
• Study First Posted: 2019-06-18
• Last Update Submitted: 2019-06-19
• Last Update Posted: 2019-06-21
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
InSurE group	traditional InSurE	receives intubation-surfactant- extubation technique and selects CPAP ventilation
LISA+SNIPPV group	LISA+SNIPPV	receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation

Primary Outcome Measures

Name	Time	Method
the duration of oxygen therapy	40 weeks	the duration of oxygen therapy of each group
the incidence of BPD	28 days	the incidence of BPD in each group
the average duration of mechanical ventilation	40 weeks	the average duration of mechanical ventilation of each group

Secondary Outcome Measures

Name	Time	Method
the incidence of complications	40 weeks	the incidence of complications (e.g. necrotizing enterocolitis, cholestasis, retinopathy of prematurity, extrauterine growth retardation)
oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2)	the period of oxygen therapy	oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2)
Pulmonary Severity Score (PSC)	1st, 2nd, 3rd, 7th, 14th, 28th days	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, China