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A Prospective Randomised Controlled Trial of Budesonide Instillation into the Trachea in Neonatal Hypoxic Respiratory Failure

A Prospective Randomised Controlled Trial of Budesonide Instillation into the Trachea in Neonatal Hypoxic Respiratory Failure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120179
Enrollment
Unknown
Registered
2026-03-10
Start date
2026-03-10
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

Hypoxic respiratory failure in newborns

Interventions

Experimental group:Endotracheal instillation of 0.25 mg/kg budesonide (for 3 consecutive days) in combination with standard treatment
Control group:Conventional treatment

Sponsors

Qujing Maternity and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. For diagnosing neonatal respiratory distress syndrome, it is necessary for the neonates who require invasive ventilator treatment and have not received PS treatment before admission. 2. For diagnosing neonatal meconium aspiration pneumonia, respiratory distress occurs within 6 hours after birth. 3. For diagnosing neonatal acute respiratory distress syndrome and those requiring invasive ventilator treatment. 4. For neonates with low-oxygen respiratory failure caused by other diseases and requiring invasive ventilator support treatment. 5. Parents/guardians give informed consent, agreeing to anonymize the data for research purposes.

Exclusion criteria

Exclusion criteria: 1. Severe congenital heart disease, severe congenital malformations or genetic metabolic disorders; 2. Parents do not wish to participate in the study; 3. Newborns die within 24 hours or are given up for treatment.

Design outcomes

Primary

MeasureTime frame
Arterial Blood Gas (ABG) values;Duration of invasive ventilator use;Oxygen usage time;

Secondary

MeasureTime frame
Length of hospital stay;Blood;Blood sugar;

Countries

China

Contacts

Public ContactChuanfeng Li;Dan Li

Qujing Maternity and Child Health Hospital

1060318663@qq.com+86 139 8897 0311

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026