Nasal High-frequency Oscillatory Ventilation (NHFOV) for Ventilated Newborn Infants With BPD

NCT04905732 | Unknown DMC

• 1 other identifier: NHFOV for sBPD
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Invasive ventilation(IV) remains one key cornerstone to reduce neonatal mortality for preterm infants with respiratory distress syndrome(RDS) and/or acute respiratory distress syndrome(ARDS). However, it is also related to increased risks of ventilator-associated lung injury and escalation of pulmonary inflammation, and which finally result in bronchopulmonary dysplasia (BPD). Early weaning from IV in newborn infants with BPD is therefore a key procedure to reduce these risks above.

Conditions

Bronchopulmonary Dysplasia; Nasal High-frequency Oscillatory Ventilation; Nasal Continuous Positive Airway Pressure; Neonate

Outcome Measures

Primary Outcomes (3)

• re-intubation rate

  the newborn infants with ventilated BPD is reintubated after extubation

  seven days after extubation

• death

  the newborn infants with BPD die

  seven days after extubation

• the level of carbon dioxide

  the level of carbon dioxide is measure after extubation between groups

  seven days after extubation

Secondary Outcomes (2)

• necrotizing entercolitis(NEC)

  seven days after extubation

• intraventricular hemorrhage(IVH)

  seven days after extubation

Study Arms (2)

NHFOV

EXPERIMENTAL

After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV

Device: NHFOV

NCPAP

ACTIVE COMPARATOR

After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP

Device: NCPAP

Interventions

NHFOV DEVICE

After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV

NHFOV

NCPAP DEVICE

After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP

NCPAP

Eligibility Criteria

• Age: 28 Days - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Eligibility requirements for neonates:
• The gestational age is less than 32 weeks
• The preterm neonates are diagnosed with BPD and need invasive ventilation
• Extubation and subsequent noninvasive ventilation is ready to be carried out

You may not qualify if:

• one of the following conditions is needed:
• there were no intraventricular hemorrhage(IVH) grades 3 or 4
• major congenital anomalies
• parents' decision not to participate

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead
• Children's Hospital of Chongqing Medical University: collaborator

Study Sites (1)

Chen（陈）

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Chen（陈） Long, MD, PhD

CONTACT

+8613883559467; neuroclong@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After documenting parental consent, these ventilated infants with BPD were randomly assigned to either NHFOV or NCPAP using a table of random numbers and sealed opaque envelopes when they were eligible for extubation. Blinding to doctor was not possible due to the nature of the intervention, is not necessary to participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Model Details: After documenting parental consent, the ventilated infants with BPD were randomly assigned to either NHFOV or NCPAP

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: May 28, 2021
• Study Start: May 20, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

CN (1)