Surfactant Administration by Insure or Thin Catheter

Study Overview
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Brief Summary
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This trial evaluates the efficacy and safety of surfactant administration with thin catheter technique together with analgesic premedication in comparison with the established INSURE-strategy. It will provide valuable knowledge to improve clinical methodology and enhance lung protective treatment strategies for preterm infants.

Detailed Description
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To compare two approaches for surfactant administration during CPAP in preterm infants, the INSURE and the LISA technique, using premedication intubation protocols, and investigate aspects of safety, stress and pain, timely administration of the drug, response in oxygenation and pulmonary outcome. Our study asks whether (P) among infants born <32 weeks' gestation with RDS (I) does surfactant administration with LISA and analgesia premedication (C) versus surfactant administration according to the INSURE protocol (O) improve oxygenation and reduce the rate of respiratory failure and need for intubation and mechanical ventilation (T) within 48 hours of the procedure Primary outcomes: Positive effect: Oxygenation measured as arterial to alveolar ratio (a/A ratio) at 24 hours post-procedure. Negative effect: Need for mechanical ventilation (MV) within 48 hours post-procedure. Safety outcomes: Time from meeting the FiO2 or a/A ratio criteria for surfactant treatment until surfactant administration Number of tries before successful intubation/placement of catheter Positive pressure ventilation during the procedure - yes/no/duration (minutes) Stress and pain (changes in heart rate, blood pressure and BIIP-scale)

Official Title
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Surfactant Administration by Insure or Thin Catheter

Conditions
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RDS of Prematurity, Surfactant Deficiency Syndrome Neonatal, Analgesia

Intervention / Treatment
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* Procedure: Thin catheter technique or standard ET-tube for surfactant administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants born before 32 completed weeks of gestation on CPAP, with clinical and radiological signs of RDS and need for surfactant treatment. Exclusion Criteria: Infants requiring surfactant as part of delivery room resuscitation are not eligible. Infants will be excluded from the final analysis if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, including: congenital diaphragmatic hernia; tracheo-oesophageal fistula or cyanotic heart disease.

Ages Eligible for Study
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Maximum Age: 2 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: INSURE<br>Surfactant administration by Intubation-surfactant-extubation to CPAP according to standard protocol including premedication with analgesia and sedation. | Procedure: Thin catheter technique or standard ET-tube for surfactant administration<br>* Surfactant administration by intubation with regular ET-tube followed by immediate extubation to CPAP (INSURE) or by thin catheter during spontaneous breathing and continued CPAP.<br>|
| Active Comparator: LISA<br>Surfactant administration by thin catheter during spontaneous breathing and continued CPAP according to set protocol including premedication with analgesia. | Procedure: Thin catheter technique or standard ET-tube for surfactant administration<br>* Surfactant administration by intubation with regular ET-tube followed by immediate extubation to CPAP (INSURE) or by thin catheter during spontaneous breathing and continued CPAP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation | Arterial to alveolar ratio (a/A ratio) | 24 hours post-procedure | 
| Mechanical ventilation | Need for intubation and mechanical ventilation (MV) | 48 hours post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of ventilatory support | Duration of MV (hours), CPAP (days), Oxygen (days) | Discharge | 
| Complications | Incidence of air leaks, bronchopulmonary dysplasia, Systemic hypotension, retinopathy, necrotizing entercolitis, intraventricular hemorrhage, persistent duct | Discharge | 
| Mortality | Death or composite outcome death/BPD | Discharge | 
| Length of stay | Number of days in NICU and total in neonatal care, including home care | Discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LISA (Less invasive surfactant administration), INSURE, CPAP