Premedication for less invasive surfactant administration in preterm infants
Premedication for Less Invasive Surfactant Administration
This study is testing whether giving preterm infants either ketamine or fentanyl before a less invasive surfactant treatment can help reduce their pain while allowing them to breathe on their own.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Sex | All |
| Sponsor | University of Oulu Academic / other |
| Locations | 1 site (Oulu) |
| Trial ID | NCT03735563 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the optimal premedication for less invasive surfactant administration (LISA) in preterm infants with surfactant deficiency syndrome. The study involves randomizing eligible infants to receive either ketamine or fentanyl, alongside glucopyrrolate and caffeine, prior to the LISA procedure. The aim is to minimize procedural pain while ensuring the infants can maintain their own breathing. The trial is conducted at Oulu University Hospital and includes a total of 20 participants.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born at or after 26 weeks of gestation who require surfactant treatment and are managed with non-invasive respiratory support.
Not a fit: Patients with severe respiratory distress requiring intubation or those with significant congenital malformations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the comfort and safety of preterm infants undergoing surfactant treatment, potentially leading to better respiratory outcomes.
How similar studies have performed: While the approach of using less invasive surfactant administration is established, the specific premedication strategies being tested in this trial are novel and have not been extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gestational age at birth ≥26 weeks * Respiratory insufficiency managed with non-invasive respiratory support (nasal continuous positive airway pressure or high-flow) * Requirement for oxygen to maintain oxygen saturation in the target range and need for surfactant treatment (according to clinician's assessment) * If further doses of surfactant are needed, patient can be re-randomized Exclusion Criteria: * Severe RDS with high oxygen requirements, severe respiratory acidosis and/or widespread atelectasis radiologically, such that ongoing ventilator support will be necessary after surfactant therapy (intubation in preferable to LISA if FiO2 \>40% at GA \<28 weeks and \>60% at GA ≥28 weeks) * Maxillo-facial, tracheal or known pulmonary malformations * Any known chromosomal abnormality or severe malformation * An alternative cause for respiratory distress (e.g. congenital pneumonia or pulmonary hypoplasia)
Where this trial is running
Oulu
- Oulu University Hospital — Oulu, Finland (Recruiting)
Study contacts
- Principal investigator: Riitta Marttila, MD, docent — Oulu University and Oulu University Hospital
- Study coordinator: Eveliina Ronkainen, MD, PhD
- Email: eveliina.ronkainen@oulu.fi
- Phone: +358 8 3152011
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.