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Surfactant Administration by Insure or Thin Catheter (SAINT)

Primary Purpose

RDS of Prematurity, Surfactant Deficiency Syndrome Neonatal, Analgesia

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Thin catheter technique or standard ET-tube for surfactant administration
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for RDS of Prematurity focused on measuring LISA (Less invasive surfactant administration), INSURE, CPAP

Eligibility Criteria

undefined - 2 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Karolinska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

INSURE

LISA

Arm Description

Surfactant administration by Intubation-surfactant-extubation to CPAP according to standard protocol including premedication with analgesia and sedation.

Surfactant administration by thin catheter during spontaneous breathing and continued CPAP according to set protocol including premedication with analgesia.

Outcomes

Primary Outcome Measures

Oxygenation
Arterial to alveolar ratio (a/A ratio)
Mechanical ventilation
Need for intubation and mechanical ventilation (MV)

Secondary Outcome Measures

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

Full Information

First Posted
June 22, 2020
Last Updated
October 11, 2023
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT04445571
Brief Title
Surfactant Administration by Insure or Thin Catheter
Acronym
SAINT
Official Title
Surfactant Administration by Insure or Thin Catheter
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RDS of Prematurity, Surfactant Deficiency Syndrome Neonatal, Analgesia
Keywords
LISA (Less invasive surfactant administration), INSURE, CPAP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
INSURE
Arm Type
Active Comparator
Arm Description
Surfactant administration by Intubation-surfactant-extubation to CPAP according to standard protocol including premedication with analgesia and sedation.
Arm Title
LISA
Arm Type
Active Comparator
Arm Description
Surfactant administration by thin catheter during spontaneous breathing and continued CPAP according to set protocol including premedication with analgesia.
Intervention Type
Procedure
Intervention Name(s)
Thin catheter technique or standard ET-tube for surfactant administration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oxygenation
Description
Arterial to alveolar ratio (a/A ratio)
Time Frame
24 hours post-procedure
Title
Mechanical ventilation
Description
Need for intubation and mechanical ventilation (MV)
Time Frame
48 hours post-procedure
Secondary Outcome Measure Information:
Title
Duration of ventilatory support
Description
Duration of MV (hours), CPAP (days), Oxygen (days)
Time Frame
Discharge
Title
Complications
Description
Incidence of air leaks, bronchopulmonary dysplasia, Systemic hypotension, retinopathy, necrotizing entercolitis, intraventricular hemorrhage, persistent duct
Time Frame
Discharge
Title
Mortality
Description
Death or composite outcome death/BPD
Time Frame
Discharge
Title
Length of stay
Description
Number of days in NICU and total in neonatal care, including home care
Time Frame
Discharge
Other Pre-specified Outcome Measures:
Title
Delay time
Description
Time from meeting the FiO2 or a/A ratio criteria for surfactant treatment until surfactant administration
Time Frame
24 hours
Title
Intubation attempts
Description
Number of tries before successful intubation/placement of catheter
Time Frame
24 hours
Title
PPV
Description
Positive pressure ventilation during the procedure - yes/no/duration (minutes)
Time Frame
24 hours
Title
Stress and pain
Description
Changes in heart rate, blood pressure and BIIP-scales
Time Frame
24 hours

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kajsa Bohlin, MD
Phone
+46858580000
Ext
81356
Email
kajsa.bohlin@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Mats Blennow, MD
Phone
+46858580000
Ext
81428
Email
mats.blennow@ki.se
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kajsa Bohlin, MD
Phone
0858580000
Ext
81356
Email
kajsa.bohlin@ki.se
First Name & Middle Initial & Last Name & Degree
Mats Blennow, MD
Phone
0858580000
Ext
81428
Email
mats.blennow@ki.se

12. IPD Sharing Statement

Plan to Share IPD
No

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Surfactant Administration by Insure or Thin Catheter

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