Nasal High Frequency Oscillation for Respiratory Distress Syndrome in Twins Infants

NCT03206489 | Unknown DMC

• 1 other identifier: twins with HFO
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Nasal High Frequency Oscillation Ventilation

Outcome Measures

Primary Outcomes (1)

• intubation

  the baby is re-intubated.

  during the first 7 days after birth

Secondary Outcomes (2)

• Bronchopulmonary dysplasia(BPD)

  at a post-menstrual age of 36 weeks or at discharge

• Bayley Scales of Infant Development

  30 months after birth

Study Arms (2)

nHFOV

EXPERIMENTAL

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)

nCPAP

ACTIVE COMPARATOR

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)

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

nHFOV

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

nCPAP

Eligibility Criteria

• Age: 30 Minutes - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Shi Yuan, PhD,MD

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

  STUDY DIRECTOR

Central Study Contacts

Chen Long, MD

CONTACT

13883559467; 476679422@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Model Details: 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

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 2, 2017
• Study Start: August 1, 2017
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)