Skip to content

Role of a drug in neonates for the treatment of breathlessness at birth due to retention of fluid in lung

Role of inhaled beta-2 agonist for the treatment of transient tachypnea of newborn

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/01/007624
Enrollment
20
Registered
2017-01-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: - Health Condition 2: J988- Other specified respiratory disorders Health Condition 3: null- Transient tachypnea of newborn

Interventions

Intervention1: Inhaled beta-2 agonist use in treatment of transient tachypnea of newborn: Salbutamol will be given as one nebulized dose in patients randomized to receive treatment as standard dose of
one dose will be administered over the course of 20 minutes. Control Intervention1: Standard treatment for transient tachypnea of newborn: Nasal continuous positive airway pressure with oxygen and int

Sponsors

St Stephens Hospital
Lead Sponsor
Dr pinky bahl
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Neonates more than 34 weeks diagnosed as transient tachypnea of newborn according to: - symptoms within first 6 hours after birth - x-ray chest consistent with retained fetal lung fluid

Exclusion criteria

Exclusion criteria: 1.premature infants less than 35 weeks 2. Neonates with meconium aspiration syndrome or septecemia 3.neonates with hyaline memberane disease 4.neonates with birth asphyxia 5. Neonates with congenital heart disease

Design outcomes

Primary

MeasureTime frame
To evaluate improvement in respiratory distress based on respiratory rate and TTN scoreTimepoint: To evaluate improvement in respiratory distress based on respiratory rate and TTN score

Secondary

MeasureTime frame
To evaluate duration of Hospitalization in salbutamol treated group compared to standard treatment groupTimepoint: 72 hours;To evaluate oxygen requirement in salbutamol treated group as compared to standard treatment groupTimepoint: 0 hour, 1 hour and 4th hour;To evaluate type and duration of respiratory support required in salbutamol treated group as compared to standard treatment groupTimepoint: 72 hours

Countries

India

Contacts

Public ContactDr Jacob Puliyel

St.stephens Hospital Tis Hazari new delhi-110054

Jacob@puliyel.com9868035091

Outcome results

None listed

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