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

Nanjing Medical University

Status: Unknown

Conditions: Respiratory Distress Syndrome of Newborn

Treatments: Procedure: LISA+SNIPPV; Procedure: traditional InSurE

Study type: Interventional

Funder types: Other

Identifiers

NCT03989960

MOLISAN

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

LISA+SNIPPV group

Experimental group

Description:

receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation

Treatment:

Procedure: LISA+SNIPPV

InSurE group

Active Comparator group

Description:

receives intubation-surfactant- extubation technique and selects CPAP ventilation

Treatment:

Procedure: traditional InSurE