Nasal High Frequency Oscillation for Respiratory Distress Syndrome in Twins Infants

Not Applicable

Recruiting

• Conditions: Nasal High Frequency Oscillation Ventilation
• Interventions: Device: noninvasive high-frequency ventilation (nHFOV); Device: nasal continuous positive airway pressure (nCPAP)

• Registration Number: NCT03206489
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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.

Study Timeline

• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-29
• Study First Posted: 2017-07-02
• Study Start: 2017-08-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-23
• Last Update Posted: 2022-10-25
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nHFOV	noninvasive high-frequency ventilation (nHFOV)	noninvasive high-frequency ventilation (nHFOV) is used as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome
nCPAP	nasal continuous positive airway pressure (nCPAP)	nasal continuous positive airway pressure (nCPAP) is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome

Primary Outcome Measures

Name	Time	Method
intubation	during the first 7 days after birth	the baby is re-intubated.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China