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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

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.

Condition or disease Intervention/treatment Phase
RDS of Prematurity Surfactant Deficiency Syndrome Neonatal Analgesia Procedure: Thin catheter technique or standard ET-tube for surfactant administration Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surfactant Administration by Insure or Thin Catheter
Estimated Study Start Date : June 15, 2020
Estimated Primary Completion Date : March 15, 2022
Estimated Study Completion Date : June 15, 2022


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.




Primary Outcome Measures :
  1. Oxygenation [ Time Frame: 24 hours post-procedure ]
    Arterial to alveolar ratio (a/A ratio)

  2. Mechanical ventilation [ Time Frame: 48 hours post-procedure ]
    Need for intubation and mechanical ventilation (MV)


Secondary Outcome Measures :
  1. Duration of ventilatory support [ Time Frame: Discharge ]
    Duration of MV (hours), CPAP (days), Oxygen (days)

  2. Complications [ Time Frame: Discharge ]
    Incidence of air leaks, bronchopulmonary dysplasia, Systemic hypotension, retinopathy, necrotizing entercolitis, intraventricular hemorrhage, persistent duct

  3. Mortality [ Time Frame: Discharge ]
    Death or composite outcome death/BPD

  4. Length of stay [ Time Frame: Discharge ]
    Number of days in NICU and total in neonatal care, including home care


Other Outcome Measures:
  1. Delay time [ Time Frame: 24 hours ]
    Time from meeting the FiO2 or a/A ratio criteria for surfactant treatment until surfactant administration

  2. Intubation attempts [ Time Frame: 24 hours ]
    Number of tries before successful intubation/placement of catheter

  3. PPV [ Time Frame: 24 hours ]
    Positive pressure ventilation during the procedure - yes/no/duration (minutes)

  4. Stress and pain [ Time Frame: 24 hours ]
    Changes in heart rate, blood pressure and BIIP-scales



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Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445571


Contacts
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Contact: Kajsa Bohlin, MD +46858580000 ext 81356 kajsa.bohlin@ki.se
Contact: Mats Blennow, MD +46858580000 ext 81428 mats.blennow@ki.se

Locations
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Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, 14186
Contact: Kajsa Bohlin, MD    0858580000 ext 81356    kajsa.bohlin@ki.se   
Contact: Mats Blennow, MD    0858580000 ext 81428    mats.blennow@ki.se   
Sponsors and Collaborators
Karolinska Institutet
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Responsible Party: Kajsa Bohlin, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04445571    
Other Study ID Numbers: 180367
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kajsa Bohlin, Karolinska Institutet:
LISA (Less invasive surfactant administration)
INSURE
CPAP
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Respiratory System Agents