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Surfactant Administration by Insure or Thin Catheter (SAINT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04445571
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Kajsa Bohlin, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE June 22, 2020
First Posted Date  ICMJE June 24, 2020
Last Update Posted Date June 24, 2020
Estimated Study Start Date  ICMJE June 15, 2020
Estimated Primary Completion Date March 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2020)
  • Oxygenation [ Time Frame: 24 hours post-procedure ]
    Arterial to alveolar ratio (a/A ratio)
  • Mechanical ventilation [ Time Frame: 48 hours post-procedure ]
    Need for intubation and mechanical ventilation (MV)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2020)
  • Duration of ventilatory support [ Time Frame: Discharge ]
    Duration of MV (hours), CPAP (days), Oxygen (days)
  • Complications [ Time Frame: Discharge ]
    Incidence of air leaks, bronchopulmonary dysplasia, Systemic hypotension, retinopathy, necrotizing entercolitis, intraventricular hemorrhage, persistent duct
  • Mortality [ Time Frame: Discharge ]
    Death or composite outcome death/BPD
  • Length of stay [ Time Frame: Discharge ]
    Number of days in NICU and total in neonatal care, including home care
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 22, 2020)
  • Delay time [ Time Frame: 24 hours ]
    Time from meeting the FiO2 or a/A ratio criteria for surfactant treatment until surfactant administration
  • Intubation attempts [ Time Frame: 24 hours ]
    Number of tries before successful intubation/placement of catheter
  • PPV [ Time Frame: 24 hours ]
    Positive pressure ventilation during the procedure - yes/no/duration (minutes)
  • Stress and pain [ Time Frame: 24 hours ]
    Changes in heart rate, blood pressure and BIIP-scales
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Surfactant Administration by Insure or Thin Catheter
Official Title  ICMJE Surfactant Administration by Insure or Thin Catheter
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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomised controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • RDS of Prematurity
  • Surfactant Deficiency Syndrome Neonatal
  • Analgesia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: INSURE
    Surfactant administration by Intubation-surfactant-extubation to CPAP according to standard protocol including premedication with analgesia and sedation.
    Intervention: Procedure: Thin catheter technique or standard ET-tube for surfactant administration
  • Active Comparator: LISA
    Surfactant administration by thin catheter during spontaneous breathing and continued CPAP according to set protocol including premedication with analgesia.
    Intervention: Procedure: Thin catheter technique or standard ET-tube for surfactant administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 22, 2020)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 15, 2022
Estimated Primary Completion Date March 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 2 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kajsa Bohlin, MD +46858580000 ext 81356 kajsa.bohlin@ki.se
Contact: Mats Blennow, MD +46858580000 ext 81428 mats.blennow@ki.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04445571
Other Study ID Numbers  ICMJE 180367
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kajsa Bohlin, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Karolinska Institutet
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP