Clinical trial NCT03206489: Nasal High Frequency Oscillation for Respiratory Distress Syndrome in Twins Infants
Official title: Nasal High Frequency Oscillation for Respiratory Distress Syndrome in Preterm Twins Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasal High Frequency Oscillation Ventilation
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: noninvasive high-frequency ventilation (nHFOV) and nasal continuous positive airway pressure (nCPAP) are used as primary mode of ventilation in preterm twins infants with RDS
Primary purpose: TREATMENT

Brief summary: The investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -noninvasive high-frequency oscillatory ventilation (nHFOV) or nasal continuous positive airway pressure (nCPAP) -as a primary mode of ventilation in preterm twins infants with respiratory distress syndrome

Detailed description: Invasive ventilation is related to development of adverse pulmonary and nonpulmonary outcomes in ventilated infants. Various modes of noninvasive respiratory support are being increasingly used to minimize the incidence of bronchopulmonary dysplasia (BPD). The aim of this trial to compare the effects of noninvasive high frequency oscillatory ventilation (NHFOV) and nasal continuous positive airway pressure (NCPAP) in preterm twins infants as the primary mode.

Eligibility criteria: Inclusion Criteria:

1. Gestational age (GA) is from 26 to 37 weeks;
2. Diagnosis of respiratory distress syndrome. The diagnosis of respiratory distress syndrome will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings;
3. Respiratory distress syndrome Silverman score \>5;
4. Informed parental consent has been obtained.

Exclusion Criteria:

1. Severe respiratory distress syndrome requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation7;
2. Major congenital malformations or complex congenital heart disease;
3. Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage;
4. Cardiopulmonary arrest needing prolonged resuscitation;
5. transferred out of the neonatal intensive care unit without treatment.

Primary outcomes:
measure: intubation
timeFrame: during the first 7 days after birth
Secondary outcomes:
measure: Bronchopulmonary dysplasia(BPD)
timeFrame: at a post-menstrual age of 36 weeks or at discharge
measure: Bayley Scales of Infant Development
timeFrame: 30 months after birth
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
state: Chongqing
Study officials:
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Shi Yuan, PhD,MD
role: STUDY_DIRECTOR
References: