Comparison of surfactant delivery methods - Endotracheal tube vs Laryngeal mask airway

Efficacy of Surfactant administration through laryngeal or supraglottic airways (SALSA) vs Intubate-Surfactant-Extubate (INSURE) in Preterm Neonates with Respiratory Distress Syndrome: A Randomized Study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/054608

Enrollment

Registered

2023-07-03

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

Health Condition 1: P220- Respiratory distress syndrome of newborn

Interventions

Intervention1: SALSA technique: Use of laryngeal mask airway for surfactant administration (SALSA). the duration of procedure will take about 10-15 minutes Control Intervention1: INSURE technique: Use

Eligibility

Inclusion criteria

Inclusion criteria: Preterm neonates with respiratory distress syndrome on CPAP with requirement of FiO2 >0.3 and PEEP of 6cm H2O or more

Exclusion criteria

Exclusion criteria: Neonates intubated before enrolment Major congenital malformations Refusal to participate

Design outcomes

Primary

Measure	Time frame
Success of surfactant delivery: attainment of following parameters within 60 minutes of delivery of Surfactant: 1. FiO2 0.3 2. No / mild retractions 3. RR: 80 bpm Timepoint: 60 minutes after surfactant delivery	—

Secondary

Measure	Time frame
Need for invasive ventilation during 72 hrs following surfactant delivery Number of doses of surfactant required Time taken to perform the procedure Cumulative duration of respiratory support (non-invasive & invasive ventilation) during hospital stay Cumulative duration of following events during & within 10 minutes of the procedure a. Apnoea b. Preductal oxygen saturations below 85% c. Heart rate: bradycardia defined as HR 100 bpm Neonatal pain assessment with each procedure: This will be assessed by N-PASS scale Proceduralist stress score with each procedure by using Likert scale Incidence of IVH, Pneumothorax and BPD Amount of gastric leakage of surfactant Timepoint: Immediately after surfactant delivery & at discharge of the baby	—

Measure

Time frame

Need for invasive ventilation during 72 hrs following surfactant delivery Number of doses of surfactant required Time taken to perform the procedure Cumulative duration of respiratory support (non-invasive & invasive ventilation) during hospital stay Cumulative duration of following events during & within 10 minutes of the procedure a. Apnoea b. Preductal oxygen saturations below 85% c. Heart rate: bradycardia defined as HR 100 bpm Neonatal pain assessment with each procedure: This will be assessed by N-PASS scale Proceduralist stress score with each procedure by using Likert scale Incidence of IVH, Pneumothorax and BPD Amount of gastric leakage of surfactant Timepoint: Immediately after surfactant delivery & at discharge of the baby

—

Countries

India

Contacts

Public ContactSrikanth kandi

Sir Gangaram Hospital

kandisrikanth@yahoo.com8247785484

Outcome results

None listed

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