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A prospective, observational cohort study on early screening of neonates with poor prognosis in NARDS and accurate diagnosis of Pre-sNARDS

A prospective, observational cohort study on early screening of neonates with poor prognosis in NARDS and accurate diagnosis of Pre-sNARDS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093854
Enrollment
Unknown
Registered
2024-12-12
Start date
2025-01-01
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

Neonatal Acute Respiratory Distress Syndrome

Interventions

Case series:No intervention

Sponsors

Shenzhen Nanshan Maternity and Child Healthcare Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: 1. Study Population: (1) Term infants: For neonates with a gestational age of >= 40 weeks, the evaluation period is defined as the interval from birth to 4 weeks postnatally. For neonates with a gestational age = 16. 7. Hospitalization duration > 24 hours. 8. Informed consent signed by the guardian.

Exclusion criteria

Exclusion criteria: 1.RDS due to primary surfactant deficiency (such as hyaline membrane disease), transient tach(1) Congenital malformations: Such as congenital pulmonary airway malformation (CPAM) or diaphragmatic hernia. 2. Hereditary defects: ARDS-like clinical manifestations caused by surfactant protein (PS) deficiency due to genetic defects. 3. NRDS and TTN. 4. Termination of treatment: Cases where treatment was abandoned by the family or the infant died within 24 hours of birth due to familial decisions. 5. Guardians did not sign the informed consent form at the time of enrollment.

Design outcomes

Primary

MeasureTime frame
Survival at 28 days from NARDS diagnosis;Survival at 3 years of follow up;

Secondary

MeasureTime frame
risk factors for ARDS;bronchopulmonary dysplasia (BPD);air leak;massive pulmonary hemorrhage;retinopathy of prematurity (ROP);the incidence of NEC in infants with neonatal ARDS;intraventricular hemorrhage;sepsis;neurodevelopmental impairment (NDI);serious respiratory morbidity (SRM);growth restriction;

Countries

China

Contacts

Public ContactZhang Ruolin

Shenzhen Nanshan Maternity and Child Healthcare Hospital

ruolin1112@163.com+86 755 87850088

Outcome results

None listed

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