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Efficacy and safety of inhalation of pulmonary surfactant using vibrating mesh nebulizers combined with nasal continuous positive airway pressure in the treatment of neonatal respiratory distress syndrome

Efficacy and safety of inhalation of pulmonary surfactant using vibrating mesh nebulizers combined with nasal continuous positive airway pressure in the treatment of neonatal respiratory distress syndrome

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057285
Enrollment
Unknown
Registered
2022-03-06
Start date
2022-04-01
Completion date
Unknown
Last updated
2023-10-09

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

Conditions

Neonatal respiratory distress syndrome

Interventions

Group 1 :Vibrating mesh atomization
Group 2:intubation-surfactant-extubation

Sponsors

The First Affiliated Hospital of Bengbu Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Preterm infants with gestational age < 37 weeks; 2. Meet the diagnostic criteria of RDS, 5th edition of Practical Neonatology, that is, progressive dyspnea occurs after birth, which is manifested as cyanosis, groan, trisogal sign and shortness of breath, and may further develop into respiratory failure; at the same time, lung X-ray typical findings such as ground-glass changes, air bronchogram or white lung, and other causes of respiratory distress were excluded.

Exclusion criteria

Exclusion criteria: 1. Involuntary breathing; 2. Progressive exacerbation of respiratory distress, failure to maintain oxygen saturation (FiO2 > 0.40, Pa02 60 mmHg, pH < 7.25); 3. Congenital malformations: including posterior nasal atresia, cleft palate, congenital diaphragmatic hernia, tracheoesophageal fistula, etc.; 4. Unstable cardiovascular system: such as cardiac insufficiency, hypotension, tissue hypoperperfusion, etc.; 5. Others: emphysema, pneumothorax, gastrointestinal bleeding, severe abdominal distension, local injury (including nasal mucosa, mouth and face).

Design outcomes

Primary

MeasureTime frame
Oxygenation index;pondus hydrogenii, pH;Partial pressure of carbon dioxide, PaCO2;duration of respiratory support;

Countries

China

Contacts

Public ContactXin Chen

The First Affiliated Hospital of Bengbu Medical College

chenxin@bbmc.edu.cn+86 13965263225

Outcome results

None listed

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