NCT04073173

Stress Assessment With and Without Analgesia During Surfactant Therapy in Preterm Infants.

Stress Assessment in Preterm Infants With Respiratory Distress Syndrome Treated or Not With an Analgesic Drug During the Traditional or the Less Invasive Method of Surfactant Therapy.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Virgilio Paolo Carnielli · Academic / Other
• Sex: All
• Age: 168 Days – 223 Days
• Healthy volunteers: Not accepted

Summary

This study will compare stress, changes in oxygenation and oxidative damage in preterm infants with respiratory distress syndrome (RDS) randomized to receive or not remifentanil as an analgesic drug during the administration of porcine surfactant (poractant alfa, Curosurf®) through the traditional (INSURE) or the less invasive (LISA) method.

Detailed description

At present, LISA and INSURE are both used for surfactant therapy in infants as comparable methods. However, a clear policy of using analgesics during surfactant therapy is still lacking: some neonatologists use analgesics to reduce stress and pain scores, whereas others do not approve their use due to interference with spontaneous breathing. In this open-label, randomized, phase 4 clinical trial, infants admitted to our neonatal intensive unit care (NICU) will be evaluated according to the selection criteria and then randomized to receive or not remifentanil as an analgesic drug during the administration of porcine surfactant (poractant alfa, Curosurf®) via the INSURE or LISA method: Group-1) LISA-analgesic; Group 2) LISA-no analgesic; Group-3) INSURE-analgesic; Group-4) INSURE-no analgesic. Study patients will be stratified by gestational age at birth: Block A) 23.0-27.6 weeks of gestation; Block B) 28.0-31.6 weeks of gestation. Early caffeine administration will be provided according to our NICU guidelines shortly after birth. Infants with adequate respiratory drive will be stabilized on nasal continuous positive airway pressure (CPAP; 4-8 cm of water) right after birth. Oxygen saturation targets will be 90-94%; moderate degrees of hypercarbia (PaCO2 \< 60 mmHg, provided arterial pH \>7.22) will be tolerated. Conditions mimicking respiratory distress syndrome (RDS; i.e. sepsis, air leaks, aspiration pneumonia, congenital heart disease) will be ruled out. RDS diagnosis will be clinical according to the European Guidelines. Nasal CPAP, bi-level CPAP or nasal intermittent positive pressure ventilation (synchronized or not) will be used at the discretion of the attending physician to stabilize the patients. Intubation criteria according to our NICU guidelines will be: 1. severe acidosis (defined as arterial pH\<7.20 with a partial pressure of carbon dioxide (PaCO2) \> 55 mmHg and partial pressure of oxygen (PaO2) \< 50 mmHg) with a fraction of inspired oxygen (FiO2) \> 0.50; 2. severe apnoea. Enrolled infants will be evaluated from birth to day 7 of the hospital stay.

Conditions

• Respiratory Distress Syndrome in Premature Infants

Interventions

Type	Name	Description
PROCEDURE	INSURE	Patients will be intubated by endotracheal tube, exogenous surfactant (Poractant alfa) will be administered and then they will be extubated.
PROCEDURE	LISA	Surfactant (Poractant alfa) will be directly delivered into the lungs via a fine bore catheter inserted into the trachea and then patients will be extubated.
DRUG	Analgesic, Opioid	Remifentanil (0.5-2 micrograms/kg/dose)

Timeline

• Start date: 2020-11-01
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2019-08-29
• Last updated: 2020-09-03