Surfactant Administration by Insure or Thin Catheter
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thin catheter technique or standard ET-tube for surfactant administration.
- Who it may be relevant to
- Registry conditions: RDS of Prematurity, Surfactant Deficiency Syndrome Neonatal, Analgesia. Basic parameters: up to 2 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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)
Interventions
- 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
- Oxygenation [Time frame: 24 hours post-procedure]
- Mechanical ventilation [Time frame: 48 hours post-procedure]
Secondary outcome measures (4)
- Duration of ventilatory support [Time frame: Discharge]
- Complications [Time frame: Discharge]
- Mortality [Time frame: Discharge]
- Length of stay [Time frame: Discharge]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Karolinska University Hospital — Stockholm
Identifiers
NCT: NCT04445571 · 180367