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In babies less than 28 days, nebulization with epinephrine after removing baby from ventilator versus no nebulization: A Randomized control study

Post-extubation Epinephrine Nebulization for prevention of Extubation Failure in Neonates: A Randomized control study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052241
Enrollment
152
Registered
2023-05-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Health Condition 1: P84- Other problems with newborn

Interventions

Intervention1: Population Epinephrine (P epi): Nebulization with L epinephrine 15 minutes after extubation Control Intervention1: Control group (PStd): No nebulization with epinephrine after extubatio

Sponsors

Department of Neonatology Lok Nayak hospital Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All the neonates who at the time of extubation have been ventilated for more than 2 completed days.

Exclusion criteria

Exclusion criteria: 1.Vocal cord anomalies and another anatomic abnormality of the upper airways before intubation as noticed and recorded during intubation. 2.Seconde extubation. 3. Previous use of epinephrine in neonates during hospitalization or prior to extubation. 4. Silverman Anderson score 0/10 immediately after extubation with no evidence of hypoxemia on pulse oximeter in room air over 15 minutes.

Design outcomes

Primary

MeasureTime frame
To determine the role of epinephrine nebulization in addition to standard care in successfully preventing extubation failure in term and preterm neonates.Timepoint: 48 hours after extubation

Secondary

MeasureTime frame
To determine the advantage of using post extubation epinephrine nebulization in term and preterm neonates with regard to; duration of post-extubation noninvasive respiratory support, hospital stay, time to reintubation. To determine occurrence of death, laryngeal edema, VAP, sepsis, any side effects of nebulized epinephrine.Timepoint: 28 days

Countries

India

Contacts

Public ContactDr Arunima Bhardwaj

Department of Neonatology, M.A.M.C. Delhi.New Delhi

neoashish2008@gmail.com9810694789

Outcome results

None listed

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