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Search / Trial NCT06404294

The External Diaphragm Pacemaker Assisted Extubation in Premature Infants With Invasive Mechanical Ventilation

Launched by CHILDREN'S HOSPITAL OF CHONGQING MEDICAL UNIVERSITY · May 5, 2024

Trial Information

Current as of July 27, 2025

Recruiting

Keywords

External Diaphragm Pacemaker Invasive Mechanical Ventilation Extubation Preterm Infants

ClinConnect Summary

This clinical trial is studying a new treatment called external diaphragm pacemaker therapy for premature infants who have been on invasive mechanical ventilation for at least a week. The goal is to see if this treatment can help these babies breathe better and reduce the time they need to be on the ventilator. Researchers believe that using this therapy may strengthen the diaphragm, which is the main muscle used for breathing, and help prevent complications that can arise from long-term use of mechanical ventilation.

To be eligible for the trial, infants must be born between 28 to 35 weeks of pregnancy and have been on mechanical ventilation for seven days or more. Parents will need to provide consent for their child to participate. Throughout the trial, participants will be monitored to assess the safety and effectiveness of the pacemaker therapy. This research could lead to better treatment options for premature infants with breathing difficulties, ultimately improving their recovery and reducing hospital stays.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Premature infants at 28 to 35 weeks.
  • 2. The premature infant whose invasive mechanical ventilation time ≥7 days.
  • 3. Parents sign an informed consent form.
  • Exclusion Criteria:
  • 1. The premature infant with congenital airway malformation confirmed by chest CT or bronchofiberscopy.
  • 2. The premature infant with congenital genetic metabolic disease.
  • 3. The premature infant with complex congenital heart disease.
  • 4. The premature infant undergoing surgery.
  • 5. The premature infant with severe brain damage.
  • 6. The premature infant with neuromuscular diseases.
  • 7. The premature infant with congenital skin disease, local skin damage or infection.

About Children's Hospital Of Chongqing Medical University

The Children's Hospital of Chongqing Medical University is a leading pediatric healthcare institution in China, dedicated to advancing child health through innovative clinical research and comprehensive medical care. As a prominent clinical trial sponsor, the hospital focuses on developing and evaluating new treatments and interventions for a wide range of pediatric conditions. With a commitment to improving health outcomes for children, the institution leverages its expertise in pediatric medicine, state-of-the-art facilities, and collaboration with academic and research partners to conduct rigorous clinical trials that adhere to the highest ethical and scientific standards.

Locations

Chongqing, Chongqing, China

Patients applied

0 patients applied

Trial Officials

Yuan Shi, M.D

Study Director

Children's Hospital of Chongqing Medical University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported