Clinical trial NCT03989960: Modified Intubation-surfactant-extubation (InSurE) Technique in Preterm Neonates With Respiratory Distress Syndrome
Official title: Application of Modified Intubation-surfactant-extubation (InSurE) Technique in Preterm Neonates With Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Distress Syndrome of Newborn
Keywords: InSurE
LISA
SNIPPV
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 120
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: the average duration of mechanical ventilation
timeFrame: 40 weeks
measure: the duration of oxygen therapy
timeFrame: 40 weeks
measure: the incidence of BPD
timeFrame: 28 days
Secondary outcomes:
measure: Pulmonary Severity Score (PSC)
timeFrame: 1st, 2nd, 3rd, 7th, 14th, 28th days
measure: the incidence of complications
timeFrame: 40 weeks
measure: oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2)
timeFrame: the period of oxygen therapy
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Xiaoqing Chen, Dr
role: STUDY_DIRECTOR
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