Using a diaphragm pacemaker to help premature infants breathe without a ventilator
A Randomized Controlled Study of the External Diaphragm Pacemaker Assisted Extubation in Premature Infants With Invasive Mechanical Ventilation
This study is testing if a special device can help premature babies breathe on their own without a ventilator after they've been on one for a while.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 1 Day to 3 Months |
| Sex | All |
| Sponsor | Children's Hospital of Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT06404294 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of an external diaphragm pacemaker to assist in the extubation process of premature infants who have been on invasive mechanical ventilation for over a week. The goal is to reduce the duration of mechanical ventilation and improve the success rate of extubation by addressing respiratory muscle atrophy, which is common in these infants. By stimulating the diaphragm, the study aims to enhance respiratory function and decrease complications associated with prolonged ventilation. The research is conducted at the Children's Hospital of Chongqing Medical University.
Who should consider this trial
Good fit: Ideal candidates for this study are premature infants aged 28 to 35 weeks who have been on invasive mechanical ventilation for at least 7 days.
Not a fit: Patients with congenital airway malformations, severe brain damage, or other significant congenital conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the time premature infants spend on mechanical ventilation and lower the risk of associated complications.
How similar studies have performed: While there have been studies on diaphragm stimulation in adults and older children, this specific approach in premature infants is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chongqing, Chongqing Municipality
- Children's hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jianhui Wang, M.D
- Email: wangjh@cqmu.edu.cn
- Phone: +86-13678428167
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.