NCT02872415

Effect of Site on Pain in Preterm Neonates

Impact of Alternative Blood Glucose Testing Site (Forearm) on Pain Reduction in Preterm Neonates.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 3 Hours – 72 Hours
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Great Premature Newborn

Interventions

Type	Name	Description
BIOLOGICAL	Blood puncture site	Blood puncture site

Timeline

• Start date: 2017-05-10
• Primary completion: 2018-04-06
• Completion: 2023-05-25
• First posted: 2016-08-19
• Last updated: 2023-05-26

Locations

1 site across 1 country: France