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NCT06811428: NeoCALM
Neonatal Comfort Seat Allowing Safe Lumbar Puncture and Minimizing Failure: a Randomized Controlled Trial
NA trial testing A novel device for immobilization of babies undergoing upright LP, the present working name (non-proprietary) for the device is LP Comfort Seat (LPCS) in Sepsis in 68 participants. Not yet recruiting.
1 March 2026
Quick facts
| Lead sponsor | Joel Cox |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 68 |
| Start date | 1 March 2025 |
| Primary completion | 1 March 2026 |
| Estimated completion | 1 April 2026 |
Drugs / interventions tested
- A novel device for immobilization of babies undergoing upright LP, the present working name (non-proprietary) for the device is LP Comfort Seat (LPCS)
- Standard of Care (SOC) — full drug profile →
Conditions studied
- Sepsis — all drugs for Sepsis →
- Meningitis — all drugs for Meningitis →
Sponsor
Joel Cox
Who can join
Adults 0 Days to 28 Days, any sex, with Sepsis or Meningitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A research trial which compares standard of care against employing a novel device for immobilization of babies undergoing upright LP, the present working name for the device is LP Comfort Seat (LPCS). The research question is: P: In late-preterm to term babies who are 0-28 days and undergoing LP for R/O Sepsis I: Is the LPCS more effective C: Than human/RN assisted upright positioning O: In generating a higher rate of first attempt LP success Primary outcome measure is first attempt LP success (any evidence of CSF which is diagnostically useful by content and volume) Secondary outcome measures could include 1. A qualitatively unadulterated tap (no blood) although as you know this is hard to control even with perfect positioning and technique and single pass 2. A difference in FLACC score as measure of overall pain/comfort between test and control
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06811428
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT06811428 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Joel Cox
- Last refreshed: 6 February 2025
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/NCT06811428.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing