Nasal High Frequency Oscillation for Respiratory Distress Syndrome in Twins Infants

N/AUnknownNCT03206489

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University200 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Nasal High Frequency Oscillation Ventilation

Interventions

noninvasive high-frequency ventilation (nHFOV)DEVICE

noninvasive high-frequency ventilation (nHFOV) as a primary mode of ventilation in one of the preterm twins infants with respiratory distress syndrome

nasal continuous positive airway pressure (nCPAP)DEVICE

nasal continuous positive airway pressure (nCPAP) as a primary mode of ventilation in another of the preterm twins infants with respiratory distress syndrome

Eligibility

Sex: ALLMin age: 30 MinutesMax age: 6 Hours

Medical Language ↔ Plain English

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.

Locations (1)

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

intubation

the baby is re-intubated.

Time frame: during the first 7 days after birth

Secondary Outcomes

Bronchopulmonary dysplasia(BPD)

BPD was defined according to the National Institutes of Health consensus definition

Time frame: 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

Time frame: 30 months after birth

Central Contacts

Chen Long, MD

CONTACT

13883559467 476679422@qq.com

Data from ClinicalTrials.gov

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