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

Phase 4

Not yet recruiting

Conditions: Respiratory distress syndrome of newborn,

Registration Number: CTRI/2023/07/054608

Lead Sponsor: Srikanth kandi

Brief Summary: Surfactantreplacement therapy is one of the most common procedures performed in the neonatalintensive care unit for preterm neonates. Intubate,Surfactant, Extubate is the most commonly used technique,which involves intubation and may result in ventilator associated lung injury. Surfactant administration through laryngeal andsupraglottic airways is a newer modality in which a supraglottic airway deviceis used to deliver surfactant, thus eliminating the need for intubation and itsadverse effects. We plan to conduct this randomized control trial with non-inferioritystudy design. During the study, we anticipate enrolling at least 20 subjects ineach group, consisting of preterm neonates with respiratory distress syndrome whoreceive surfactant through either of the two techniques. The primary outcome issuccess of surfactant therapy which is defined by the attainment of thefollowing parameters within 60 minutes of administration of surfactant: FiO2<0.3, no/minimal retractions and respiratory rate <80 bpm. The Surfactant administration through laryngeal andsupraglottic airways is anticipated to be non-inferior to conventionaltechnique, however with certain other benefits like ease of delivery, lesserdiscomfort and instability of the neonate. The secondary outcome measures willbe need for invasive ventilation within 72 hours of surfactant delivery, numberof doses of surfactant required, total time taken to perform the procedure,gastric leakage of surfactant, cumulative duration of respiratory support (bothinvasive and non-invasive) during hospital stay, total duration of thefollowing events during and within 10 minutes after delivery of surfactant - apnea,preductal oxygen saturation <85% and heart rate less than 100 bpm, incidenceof pneumothorax, bronchopulmonary dysplasia and intraventricular hemorrhage,Neonatal pain assessment will be done using Neonatal-Pain Agitation and SedationScale and proceduralist stress scorewill be assessed by Likert scale.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

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

Neonates intubated before enrolment Major congenital malformations Refusal to participate.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Need for invasive ventilation during 72 hrs following surfactant delivery	Number of doses of surfactant required

Trial Locations

Locations (1): Sir Gangaram Hospital
🇮🇳
Central, DELHI, India
Sir Gangaram Hospital
🇮🇳Central, DELHI, India
Dr srikanth kandi
Principal investigator
8247785484
kandisrikanth@yahoo.com