Analgesia, RDS of Prematurity, Surfactant Deficiency Syndrome Neonatal
Conditions
Keywords
LISA (Less invasive surfactant administration), INSURE, CPAP
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)
Interventions
PROCEDUREThin 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.
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygenation | 24 hours post-procedure | Arterial to alveolar ratio (a/A ratio) |
| Mechanical ventilation | 48 hours post-procedure | Need for intubation and mechanical ventilation (MV) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of ventilatory support | Discharge | Duration of MV (hours), CPAP (days), Oxygen (days) |
| Length of stay | Discharge | Number of days in NICU and total in neonatal care, including home care |
| Complications | Discharge | Incidence of air leaks, bronchopulmonary dysplasia, Systemic hypotension, retinopathy, necrotizing entercolitis, intraventricular hemorrhage, persistent duct |
| Mortality | Discharge | Death or composite outcome death/BPD |
Other
| Measure | Time frame | Description |
|---|---|---|
| PPV | 24 hours | Positive pressure ventilation during the procedure - yes/no/duration (minutes) |
| Stress and pain | 24 hours | Changes in heart rate, blood pressure and BIIP-scales |
| Intubation attempts | 24 hours | Number of tries before successful intubation/placement of catheter |
| Delay time | 24 hours | Time from meeting the FiO2 or a/A ratio criteria for surfactant treatment until surfactant administration |
Countries
Sweden
Contacts
Primary ContactKajsa Bohlin, MD
Backup ContactMats Blennow, MD
Outcome results
None listed