Last reviewed · How we verify
NCT02872415: NOBOBO
Effect of Site on Pain in Preterm Neonates
NA trial testing Blood puncture site in Great Premature Newborn in 81 participants. Completed in 25 May 2023.
6 April 2018
Quick facts
| Lead sponsor | Assistance Publique Hopitaux De Marseille |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | diagnostic |
| Enrollment | 81 |
| Start date | 10 May 2017 |
| Primary completion | 6 April 2018 |
| Estimated completion | 25 May 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- Blood puncture site — full drug profile →
Conditions studied
- Great Premature Newborn — all drugs for Great Premature Newborn →
Sponsor
Assistance Publique Hopitaux De Marseille — full company profile →
Who can join
Adults 3 Hours to 72 Hours, any sex, with Great Premature Newborn. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Numerous experimental and clinical studies have shown that preterm neonates are particularly sensitive to stress. Preterm neonates routinely undergo painful invasive procedures. Each situation causing pain or discomfort can alter their development and cause short term cardiovascular consequences but also have long-term neurocognitive influences. Repetitive procedural pain can also lead to changes in the pain sensitivity threshold therefore. The most common painful procedures are lancing for blood glucose testing. In adults, infants and term newborns, forearm blood glucose testing has been demonstrated to be less painful than conventional sites (heel, fingers). But data is lacking in preterm neonates. The primary purpose of this study is to demonstrate a significant reduction in pain response during forearm blood lancing vs conventional sites (fingers, heel) in preterm neonates born up to 32 weeks gestation. This study is an interventional multicenter (3 centers), randomized, double bind trial with a cross over assignment. 60 premature neonates born between 23 to 32 weeks. Gestation with a postnatal age less than 72 hours that will undergo at least 3 blood glucose pricks will be included. The different sites will be randomly successively tested.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02872415
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Assistance Publique Hopitaux De Marseille trials
Trials by the same sponsor.
- NCT07521644 — Dysbiosis of Methanogenic Archaea and Nanoarchaea in the Oral Microbiome · NA · not yet recruiting
- NCT07357025 — Resting-State fMRI Study of Functional Connectivity After Gamma Knife Radiosurgery in Trigeminal Neuralgia · NA · not yet recruiting
- NCT07356661 — Evaluation of the Efficacy of Neurofeedback Technique Based on EEG Desynchronization in Epileptic Patients · NA · not yet recruiting
- NCT07399327 — Biomarkers of Response to SEEG Thermocoagulation · NA · not yet recruiting
- NCT06999499 — Development of an Aid to Melanoma Detection Using Artificial Intelligence Algorithms Based on Images From the VECTRA 3D · NA · not yet 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 NCT02872415 (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 Assistance Publique Hopitaux De Marseille
- Last refreshed: 26 May 2023
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/NCT02872415.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing