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Use of salbutamol mist to treat breathing problem in babies soon after birth

Effect of Nebulized Salbutamol for the Treatment of Transient Tachypnea of Newborn: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052441
Enrollment
134
Registered
2023-05-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: P288- Other specified respiratory conditions of newborn

Interventions

Intervention1: Nebulization with salbutamol: Recruited neonates will receive one dose of nebulization with 4 mL of Salbutamol Respirator solution (2.5 mg/2.5 mL in 0.9% saline solution) with a jet typ

Sponsors

All India Institute of Medical Sciences Rishikesh
Lead Sponsor
Sriparna Basu
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Consecutively delivered inborn neonates and outborn neonates admitted within 6 hours of life of gestational age =34 weeks, developing respiratory distress (tachypnea with or without nasal flaring, intercostal/subcostal/suprasternal retractions, grunting, crackles, diminished breath sounds on auscultation, cyanosis) soon after birth persisting for at least 6 hours, diagnosed as transient tachypnea of newborn (TTN) based on the modified criteria of Rawlings and Smith.

Exclusion criteria

Exclusion criteria: Neonates with: 1. Perinatal asphyxia 2. Presence of maternal risk factors for sepsis/chorioamnionitis 3. Major congenital and/or chromosomal anomaly 4. Lack of parental consent

Design outcomes

Primary

MeasureTime frame
The duration of tachypnea defined as respiratory rate 60 per minuteTimepoint: At 96 hours or before when tachypnea resolves

Secondary

MeasureTime frame
1. The need and duration of oxygen supplementation to maintain a target SpO2 of 90-94%. 2. The need and duration of respiratory support. 3. The need and duration of mechanical ventilation. 4. Clinical assessment of respiratory distress as quantified by Downes score. 5. The time (hours) of initiation and establishment of breastfeeding/oral feeding. 6. The duration of hospital stay. 7. Adverse events while using nebulized salbutamol such as tachycardia, arrhythmia, electrolyte disturbances etc. 8. Final outcome. Timepoint: At discharge

Countries

India

Contacts

Public ContactSriparna Basu

All India Institute of Medical Sciences, Rishikesh

alisha.dhakaa@gmail.com7528032007

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026