NCT03389789

Newborn Cortical Response to Pain and Non Pharmacological Analgesia

Cortical Pain Processing in Full Term Infants, After Giving Different Non-pharmacological Analgesia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: IRCCS Burlo Garofolo · Academic / Other
• Sex: All
• Age: 3 Days – 3 Days
• Healthy volunteers: Accepted

Summary

Minor painful procedures are frequently performed on newborn infants and non-pharmacological analgesia is commonly used. As more than one analgesic method may be applied simultaneously in clinical practice, the relative contribution and efficacy of analgesic components still needs to be further elucidated. In the present study neonatal cortical brain response during four types of non-pharmacological analgesia (oral glucose, expressed breastmilk, maternal holding plus oral glucose, maternal holding plus breastfeeding) will be studied. The aim is to assess the differential effect of oral solutions (glucose, breastmilk), when given alone or in combination with maternal relationship (holding, breastfeeding). The study will test the hypothesis that the mother-infant relationship would improve the analgesic effect of oral solutions.

Conditions

• Analgesia

Interventions

Type	Name	Description
OTHER	Oral glucose solution + maternal holding	Infant will receive both the oral glucose solution and the contact with the mother
OTHER	Breastfeeding	Infants will be breastfed
OTHER	Oral glucose solution	Infant will receive only oral glucose solution without contact with the mother
OTHER	Oral expressed breastmilk	Infant will receive only oral expressed breast milk without contact with the mother

Timeline

• Start date: 2016-11-02
• Primary completion: 2017-05-31
• Completion: 2017-05-31
• First posted: 2018-01-04
• Last updated: 2018-10-03