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Using spontaneous breathing trial to determine extubation outcomes in preterm infants——a prospective, multicenter, randomized controlled clinical trial.

Using spontaneous breathing trial to determine extubation outcomes in preterm infants——a prospective, multicenter, randomized controlled clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074604
Enrollment
Unknown
Registered
2023-08-10
Start date
2023-08-15
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

preterm infants

Interventions

group of spontaneous breathing trial:Perform extubation according to the standard for spontaneous breathing test extubation
group of clinical judgment:Perform extubation based on clinical criteria

Sponsors

The Second Hospital of Shandong Universit
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Preterm infants with gestational age of 26+0 weeks to 31+6 weeks, birth weight of 600~1500g, and assisted ventilation by tracheal intubation ventilator within 7 days after birth. (2) Mechanical ventilation time >24 hours. (3) First intubation after birth and never extubation (excluding cases of replacement of tracheal intubation and continuation of mechanical ventilation immediately after accidental extubation).

Exclusion criteria

Exclusion criteria: (1) Congenital genetic metabolic diseases and severe congenital malformations. (2) Neurological and muscular diseases affecting respiratory function (such as central hypopnea syndrome, myasthenia gravis, severe perinatal asphyxia , severe intracranial hemorrhage, etc.). (3) Contraindications for non-invasive ventilator assisted ventilation (such as pneumothorax, diaphragmatic hernia, etc.). (4) Others: children deemed unsuitable for inclusion in the study by the investigator.

Design outcomes

Primary

MeasureTime frame
rate of extubation failure;

Secondary

MeasureTime frame
Number of spontaneous breathing trial;duration of spontaneous breathing trial;reasons for failure of spontaneous breathing trial;ventilator mode and parameters before extubation;non-invasive ventilator mode and parameters after extubation;re-intubation time;re-intubation ventilator parameters;non-invasive ventilator use time;re-intubation rate within 7 days;Incidence of air leakage, pneumonia, late-onset sepsis, pulmonary hemorrhage, intracranial hemorrhage, bronchopulmonary dysplasia, retinal disease of preterm infants, necrotizing enterocolitis, etc;Length of stay;Mortality rate;Tracheal intubation ventilator assisted ventilation time;

Countries

China

Contacts

Public ContactJiang Xue

The Second Hospital of Shandong University

sdxj69@163.com+86 176 6008 2857

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026