Surfactant Administration by Insure or Thin Catheter

Not Applicable

Recruiting

• Conditions: RDS of Prematurity; Surfactant Deficiency Syndrome Neonatal; Analgesia
• Interventions: Procedure: Thin catheter technique or standard ET-tube for surfactant administration

• Registration Number: NCT04445571
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

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:

1. Positive effect: Oxygenation measured as arterial to alveolar ratio (a/A ratio) at 24 hours post-procedure.

2. Negative effect: Need for mechanical ventilation (MV) within 48 hours post-procedure.

Safety outcomes:

1. Time from meeting the FiO2 or a/A ratio criteria for surfactant treatment until surfactant administration

2. Number of tries before successful intubation/placement of catheter

3. Positive pressure ventilation during the procedure - yes/no/duration (minutes)

4. Stress and pain (changes in heart rate, blood pressure and BIIP-scale)

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-24
• Study Start: 2021-05-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-12
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Infants born before 32 completed weeks of gestation on CPAP, with clinical and radiological signs of RDS and need for surfactant treatment.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LISA	Thin catheter technique or standard ET-tube for surfactant administration	Surfactant administration by thin catheter during spontaneous breathing and continued CPAP according to set protocol including premedication with analgesia.
INSURE	Thin catheter technique or standard ET-tube for surfactant administration	Surfactant administration by Intubation-surfactant-extubation to CPAP according to standard protocol including premedication with analgesia and sedation.

Primary Outcome Measures

Name	Time	Method
Mechanical ventilation	48 hours post-procedure	Need for intubation and mechanical ventilation (MV)
Oxygenation	24 hours post-procedure	Arterial to alveolar ratio (a/A ratio)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden