Last reviewed · How we verify
NCT03718507: SAFE LISA
Study on the Effects of Different Premedication for LISA on Stress and Cerebral Tissue Oxygenation in Preterm Infants
Phase 1 trial testing Fentanyl in Respiratory Distress Syndrome. Withdrawn.
20 December 2019
Quick facts
| Lead sponsor | ASST Fatebenefratelli Sacco |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Start date | 20 May 2019 |
| Primary completion | 20 December 2019 |
| Estimated completion | 20 February 2020 |
Drugs / interventions tested
- Fentanyl (fentanyl) — full drug profile →
- Sucrose 24% Oral Solution — full drug profile →
Conditions studied
- Respiratory Distress Syndrome — all drugs for Respiratory Distress Syndrome →
- Surfactant Deficiency Syndrome Neonatal — all drugs for Surfactant Deficiency Syndrome Neonatal →
- Near Infrared Spectroscopy — all drugs for Near Infrared Spectroscopy →
Sponsor
ASST Fatebenefratelli Sacco — full company profile →
Who can join
Adults 27 Weeks to 29 Weeks, any sex, with Respiratory Distress Syndrome or Surfactant Deficiency Syndrome Neonatal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Given the popularity that LISA technique has gainig in worldwide neonatal units, the lack of evidence regarding its premedication is becoming even more relevant to provide the best care to premature infants. Objective of this clinical trial is to establish the best premedication for LISA procedure considering neonatal pain assessed with premature infants pain scale, salivary cortisol levels as an indicator of stress and crSO2 values as indicators of cerebral oxygenation. Moreover, we aim to verify if sucrose 24% given orally is an effective tool for pain management in preterm neonates also in more invasive procedure, comparable to pharmacological treatment.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Opioids for procedural pain in neonates.
Kinoshita M, Olsson E, Borys F, Bruschettini M. · · 2023 · cited 9× · PMID 37350685 · DOI 10.1002/14651858.cd015056.pub3 -
Opioids for procedural pain in neonates.
Kinoshita M, Olsson E, Borys F, Bruschettini M. · · 2023 · cited 6× · PMID 37019853 · DOI 10.1002/14651858.cd015056.pub2
Verify or expand the search:
- PubMed search for NCT03718507
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fentanyl
Trials testing the same drug.
- NCT07435337 — Effect of Nalbuphine Versus Fentanyl on Hemdoynamic Effects of Laryngoscopy · Phase 4 · recruiting
- NCT07276867 — Intrathecal Dexmedetomidine-Fentanyl Combination Versus Fentanyl Alone as Adjuvant to Bupivacaine in Spinal Anesthesia f · NA · recruiting
- NCT06763705 — Comparison of Safety and Efficacy for Different Sedation Regimens During Colonoscopy · Phase 4 · recruiting
- NCT06772727 — Lidocaine-based Versus Opioid-based Induction of Anesthesia in Emergency Laparotomy · Phase 4 · completed
- NCT06561672 — Paracetamol Plus Tramadol Versus Fentanyl As Preemptive Analgesia For Enhanced Recovery After Day Case Surgeries · EARLY_PHASE1 · enrolling by invitation
Other recruiting trials for Respiratory Distress Syndrome
Currently open trials in the same condition.
- NCT07437391 — Effect of L-Carnitine Supplementation in Preterm Neonates · NA · recruiting
- NCT06807983 — LUng and Cardiac Ultrasound for REspiratory Distress in ElDerly · NA · recruiting
- NCT07154134 — Endocan and Copeptin Serum Levels in Preterm Neonates With Respiratory Distress Syndrome · recruiting
- NCT06684379 — Study on Safety and Efficacy of Two Doses of PRS CK STORM in the Modulation of the Cytokine Storm for the Treatment of A · Phase 1, PHASE2 · recruiting
- NCT06430554 — Personalized Ventilation Based on Ventilation-perfusion Mismatch and Lung Recruitability · recruiting
Other ASST Fatebenefratelli Sacco trials
Trials by the same sponsor.
- NCT07472348 — Isoniazid-Related Hepatotoxicity in Clinical Practice: Incidence and Predictors · not yet recruiting
- NCT07033416 — A Trial Of Approach Bias Modification Training During Treatment For Cocaine Use Disorder · NA · recruiting
- NCT06398054 — A Study to Investigate the Analgesic Efficacy of Ibuprofen Alone and Ibuprofen Plus Hyoscine-n- Butyl Bromide in Reducin · Phase 4 · not yet recruiting
- NCT06364735 — Entities and Variables Related to Catch-up Growth · recruiting
- NCT07343739 — Bipolar Disorder Integrative Staging: Incorporating Biomarkers Into Progression Across Stages · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03718507 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ASST Fatebenefratelli Sacco
- Last refreshed: 4 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03718507.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing