Related Experiment Video
Updated: Jul 15, 2025
Intratracheal Instillation of Stem Cells in Term Neonatal Rats
Published on: May 4, 2020
A randomised controlled trial in preterm infants comparing prophylactic with selective "less invasive surfactant
Wolfgang Göpel1, Tanja K Rausch2, Barbara Mitschdörfer3
1Department of Pediatrics, University Hospital Schleswig-Holstein, University of Lübeck, Lübeck, Germany. wolfgang.goepel@uksh.de.
Insights
Less invasive surfactant administration (LISA) is a key treatment for preterm infants. This study investigates the long-term benefits of prophylactic LISA in infants with low oxygen needs, aiming to optimize respiratory support strategies.
Area of Science:
- Neonatology
- Pediatric Pulmonology
- Clinical Trials
Background:
- Respiratory distress syndrome (RDS) is a primary cause of mortality and morbidity in preterm infants.
- Less invasive surfactant administration (LISA) is recommended for preterm infants requiring >30% supplemental oxygen.
- The prophylactic use of LISA in infants needing ≤30% oxygen and long-term outcomes remain understudied.
Purpose of the Study:
- To evaluate the long-term efficacy and safety of prophylactic Less invasive surfactant administration (LISA) in preterm infants.
- To compare lung function at age 5 years between infants receiving prophylactic LISA and those receiving standard care.
- To determine if prophylactic LISA is superior to selective treatment for preterm infants with low oxygen requirements.
Main Methods:
- A randomized controlled trial involving preterm infants (25-28 weeks gestational age) with spontaneous breathing and ≤30% supplemental oxygen.
- Infants were randomized to either prophylactic LISA or continued continuous positive airway pressure (CPAP) treatment.
- Primary outcome: forced expiratory volume in 1-second (FEV1) z-scores at age 5 years; secondary outcomes include lung function, development, and infection rates.
Main Results:
- The pro.LISA trial is designed to provide robust data on the long-term benefits of prophylactic LISA.
- Current observational data suggest approximately 50% of eligible infants receive LISA, indicating variability in practice.
- Short-term safety will be assessed, including in-hospital mortality and complications.
Conclusions:
- Robust data on the long-term benefits of prophylactic LISA are currently lacking.
- The pro.LISA trial will clarify whether prophylactic LISA should be standard care for all preterm infants or if selective treatment is more appropriate.
- Findings will inform clinical practice regarding surfactant administration in preterm neonates.
Background:
Respiratory distress syndrome is the main cause of mortality and morbidity in preterm infants. "Less invasive surfactant administration" (LISA), which describes intratracheal surfactant administration to spontaneously breathing infants via a small diameter tube, is recommended as the first-line treatment in preterm infants with more than 30% supplemental oxygen. Prophylactic use of LISA in preterm infants with less than 30% supplemental oxygen was not tested in randomised controlled trials yet, and long-term outcome data of the procedure are scarce.
Methods:
Preterm infants with a gestational age between 25 weeks + 0 days and 28 weeks + 6 days who are breathing spontaneously on continuous positive airway pressure with supplemental oxygen at or below 30% in the first hour of life will be randomised to a prophylactic LISA treatment with 100-200 mg surfactant intratracheally per kilogramme bodyweight (intervention group) or will continue the continuous positive airway pressure treatment (control group). Participants will have follow-up until age 5 years. At that time, the children will be tested by spirometry, and forced expiratory volume within 1-s z-scores will be compared between the intervention and control groups as the primary outcome parameter of the trial. Secondary endpoints include additional lung function parameters, endurance, motor development, intelligence, and sensitivity for infectious lung diseases. Short-term safety assessment will be done after completed enrolment (n = 698) and discharge of all infants. This safety assessment will include in-hospital mortality and short-term complications.
Discussion:
Robust data concerning the possible long-term benefits of prophylactic LISA treatment are lacking. The current observational data from the German Neonatal Network indicate that approximately 50% of preterm infants with supplemental oxygen at or below 30% within the first hour of life are treated with LISA. The pro.LISA trial will provide short- and long-term outcomes of preterm infants receiving prophylactic treatment and will clarify if prophylactic treatment should be given to all preterm infants or if the current practice of selective treatment if supplemental oxygen exceeds 30% is more appropriate.
Trial Registration:
German Clinical Trials Register DRKS00028086. Prospectively registered on 8 February 2022.
