Surfactant Administration by Insure or Thin Catheter

NCT04445571 | Recruiting

• 1 other identifier: 180367
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

RDS of Prematurity; Surfactant Deficiency Syndrome Neonatal; Analgesia

Keywords

LISA (Less invasive surfactant administration); INSURE; CPAP

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Duration of ventilatory support

  Discharge

• Complications

  Discharge

• Mortality

  Discharge

• Length of stay

  Discharge

Other Outcomes (4)

• Delay time

  24 hours

• Intubation attempts

  24 hours

• PPV

  24 hours

Study Arms (2)

INSURE

ACTIVE COMPARATOR

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

LISA

ACTIVE COMPARATOR

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

Interventions

Thin catheter technique or standard ET-tube for surfactant administration PROCEDURE

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.

INSURE; LISA

Eligibility Criteria

• Age: Up to 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 14186, Sweden

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome In Premature Infants; Pulmonary Atelectasis; Agnosia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kajsa Bohlin, MD

CONTACT

+46858580000; kajsa.bohlin@ki.se

Mats Blennow, MD

CONTACT

+46858580000; mats.blennow@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: May 21, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)