Nasal High Frequency Oscillation for Respiratory Distress Syndrome in Twins Infants

Nasal High Frequency Oscillation Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03206489
• Other study ID #: twins with HFO
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2022
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Chen Long, MD
• Phone: 13883559467
• Email: 476679422[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Minutes to 6 Hours

Eligibility

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.

Related Conditions & MeSH terms

• Nasal High Frequency Oscillation Ventilation
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• noninvasive high-frequency ventilation (nHFOV)
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)
nasal continuous positive airway pressure (nCPAP) as a primary mode of ventilation in another of the preterm twins infants with respiratory distress syndrome

Locations

Country	Name	City	State
China	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intubation	the baby is re-intubated.	during the first 7 days after birth
Secondary	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
Secondary	Bayley Scales of Infant Development	scores of Bayley Scales of Infant Development at 2 months old and 2 years old	30 months after birth