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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.
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:
Safety outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INSURE | Active Comparator | Surfactant administration by Intubation-surfactant-extubation to CPAP according to standard protocol including premedication with analgesia and sedation. |
|
| LISA | Active Comparator | Surfactant administration by thin catheter during spontaneous breathing and continued CPAP according to set protocol including premedication with analgesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thin catheter technique or standard ET-tube for surfactant administration | Procedure | 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kajsa Bohlin, MD | Contact | +46858580000 | 81356 | kajsa.bohlin@ki.se |
| Mats Blennow, MD | Contact | +46858580000 | 81428 | mats.blennow@ki.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Recruiting | Stockholm | 14186 | Sweden |
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| ID | Term |
|---|---|
| C566881 | Respiratory Distress Syndrome In Premature Infants |
| D001261 | Pulmonary Atelectasis |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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Randomised controlled trial
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| 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 |
| 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 |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |