Nasal High Frequency Oscillation for Respiratory Distress Syndrome in Twins Infants

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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chen Long, MD; Phone Number: 86 13883559467; Email: 476679422@qq.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Recruiting
      • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
      • Contact: Chen Long, PhD,MD; Phone Number: 13508300283; Email: petshi530@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nHFOV; 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); noninvasive high-frequency ventilation (nHFOV) as a primary mode of ventilation in one of the preterm twins infants with respiratory distress syndrome
Active Comparator: 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	Device: 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

What is the study measuring?

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
Bayley Scales of Infant Development	scores of Bayley Scales of Infant Development at 2 months old and 2 years old	30 months after birth
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: June 29, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 23, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: twins with HFO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No