Surfactant Administration by Insure or Thin Catheter (SAINT)

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.

Study Overview

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

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)

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kajsa Bohlin, MD; Phone Number: 81356 +46858580000; Email: kajsa.bohlin@ki.se
• Study Contact Backup: Name: Mats Blennow, MD; Phone Number: 81428 +46858580000; Email: mats.blennow@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden, 14186
    • Recruiting
    • Karolinska University Hospital
    • Contact: Kajsa Bohlin, MD; Phone Number: 81356 0858580000; Email: kajsa.bohlin@ki.se
    • Contact: Mats Blennow, MD; Phone Number: 81428 0858580000; Email: mats.blennow@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 days (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: INSURE; 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; 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.
Active Comparator: LISA; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delay time	Time from meeting the FiO2 or a/A ratio criteria for surfactant treatment until surfactant administration	24 hours
Intubation attempts	Number of tries before successful intubation/placement of catheter	24 hours
PPV	Positive pressure ventilation during the procedure - yes/no/duration (minutes)	24 hours
Stress and pain	Changes in heart rate, blood pressure and BIIP-scales	24 hours

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: LISA (Less invasive surfactant administration); INSURE; CPAP
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory System Agents; Pulmonary Surfactants
• Other Study ID Numbers: 180367

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No