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Safety of two weaning strategies after high frequency oscillatory ventilation in premature infants with respiratory distress syndrome: a prospective randomized controlled trial

Safety of two weaning strategies after high frequency oscillatory ventilation in premature infants with respiratory distress syndrome: a prospective randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038281
Enrollment
Unknown
Registered
2020-09-15
Start date
2019-06-01
Completion date
Unknown
Last updated
2020-12-14

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

Conditions

Ppremature infants with respiratory distress syndrome

Interventions

Experimental group:weaning from high-frequency oscillatory ventilation directly
control group:switching and subsequent weaning and extubating from conventional mechanical ventilation

Sponsors

Xiamen Maternal and Child Care Hospital, Women and Children's Hospital, School of Medicine, Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children diagnosed with NRDS; 2. Premature infants with GA <= 32 + 6 weeks or BW <= 1500g; 3. Infants born in our hospital should be admitted within 2 hours after birth; 4. HFOV is the first choice and mechanical ventilation is more than 24 hours.

Exclusion criteria

Exclusion criteria: 1. Children with congenital malformations; 2. The subjects of genetic metabolic diseases; 3. The subjects of grade 3-4 intracranial hemorrhage; 4. Children whose family members do not agree to use HFOV or PS; 5. Family members give up treatment or the child dies.

Design outcomes

Primary

MeasureTime frame
reintubation rate after 72 hours of ventilator withdrawal;invasive mechanical ventilation time;total mechanical ventilation time;total oxygen consumption time;the level of partial pressure of carbon dioxide (PaCO2) after 2 hours when extubated from HFOV;

Secondary

MeasureTime frame
the incidence rate of bronchopulmonary dysplasia;the incidence rate of intraventricular hemorrhage;the incidence rate of periventricular leukomalacia;the incidence rate of ventilator associated pneumonia;the incidence of air leakage syndrome;the incidence of retinopathy of prematurity;hospitalization time;

Countries

China

Contacts

Public ContactLin Xinzhu

Xiamen Maternal and Child Care Hospital, Women and Children's Hospital, School of Medicine, Xiamen University

xinzhufj@163.com+86 592-2662031

Outcome results

None listed

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