Nasal High Frequency Oscillation for Respiratory Distress Syndrome in Twins Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nasal High Frequency Oscillation for Respiratory Distress Syndrome in Preterm Twins Infants

Conditions
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Nasal High Frequency Oscillation Ventilation

Intervention / Treatment
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* Device: noninvasive high-frequency ventilation (nHFOV)
* Device: nasal continuous positive airway pressure (nCPAP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age (GA) is from 26 to 37 weeks; 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; Respiratory distress syndrome Silverman score >5; Informed parental consent has been obtained. Exclusion Criteria: Severe respiratory distress syndrome requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation7; Major congenital malformations or complex congenital heart disease; Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage; Cardiopulmonary arrest needing prolonged resuscitation; transferred out of the neonatal intensive care unit without treatment.

Ages Eligible for Study
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Minimum Age: 30 Minutes
Maximum Age: 6 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nHFOV<br>noninvasive high-frequency ventilation (nHFOV) is used as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome | Device: noninvasive high-frequency ventilation (nHFOV)<br>* noninvasive high-frequency ventilation (nHFOV) as a primary mode of ventilation in one of the preterm twins infants with respiratory distress syndrome<br>|
| Active Comparator: nCPAP<br>nasal continuous positive airway pressure (nCPAP) is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome | Device: nasal continuous positive airway pressure (nCPAP)<br>* nasal continuous positive airway pressure (nCPAP) as a primary mode of ventilation in another of the preterm twins infants with respiratory distress syndrome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intubation | the baby is re-intubated. | during the first 7 days after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchopulmonary dysplasia(BPD) | BPD was defined according to the National Institutes of Health consensus definition | at a post-menstrual age of 36 weeks or at discharge | 
| Bayley Scales of Infant Development | scores of Bayley Scales of Infant Development at 2 months old and 2 years old | 30 months after birth |