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Nebulised Surfactant Combined With Non-Invasive Mechanical Ventilation in Preterm Neonates With Respiratory Distress Syndrome (RDS)

Nebulised Surfactant Combined With Non-Invasive Mechanical Ventilation in Preterm Neonates With Respiratory Distress Syndrome (RDS)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035547
Enrollment
Unknown
Registered
2020-08-13
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-08-17

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

Control Group:Non-invasive Mechanical Ventilation (NIPPV or NCPAP)
Experimental Group:Nebulised Surfactant Combined With Non-invasive Mechanical Ventilation (NIPPV or NCPAP)

Sponsors

Guangdong Women and Children Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Fetal age <= 28 weeks and birth weight <= 1000g; 2. Aged <= 6 hours after birth; 3. Those who meet the RDS Diagnostic Standards for Practical Neonatology (4th edition); 4. With the infant's guardian's informed consent.

Exclusion criteria

Exclusion criteria: 1. Preterm infants need invasive mechanical ventilation when admitted in NICU; 2. Congenital malformations of the respiratory system, complex congenital heart disease, severe intrauterine infection, severe instability of the circulatory system, congenital genetic metabolic diseases and chromosomal diseases; 3. Those who fail to complete the study and cannot provide complete data.

Design outcomes

Primary

MeasureTime frame
Percentage of neonates with respiratory failure of each group ;The incidence of bronchopulmonary (BPD) in each group ;

Secondary

MeasureTime frame
The duration of mechanical ventilation;The duration of oxygen therapy ;Blood gas;Vital signs;Ventilator parameters;The incidence of complications (necrotizing enterocolitis, intracranial hemorrhage, cholestasis, retinopathy of prematurity, extrauterine growth retardation, pneumothorax/air leak);The incidence of death;

Countries

China

Contacts

Public ContactLiu Ying

Guangdong Women and Children Hospital

liuying860101@126.com+86 15919302287

Outcome results

None listed

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