NCT01276366

Amphia Premature Infant Pain Study

Amphia Premature Infant Pain Study; Breast Milk vs Sucrose

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Amphia Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 2 Months
• Healthy volunteers: Accepted

Summary

Last thirty years, many research was performed concerning pain in the newborn. These investigations showed us the negative effects of pain in the neonatal period. Our research concerns the choice of analgesics for the premature newborn during a heel lance. Newborns with a gestational age of 32-37 weeks are randomly assigned over three groups. They can receive breastfeeding, during the heel lance, a bottle with supplemental breast milk or sucrose. The primary objective of the Amphia Premature Infant Pain study, is to investigate whether there is a difference in PIPP-scores in premature newborns who undergo a heel lance, receiving breast milk or sucrose. Our hypothesis is that the PIPP-score will be lower in newborns receiving breast milk compared to sucrose. And the investigators presume that breast feeding has the same analgesic effect as giving supplemental breast milk.

Conditions

• Premature Infant
• Breast Feeding, Exclusive
• Puncture Skin

Interventions

Type	Name	Description
OTHER	breast feeding	Newborns who are assigned to group one, receive breastfeeding during the blood sample and thereby have skin-skin contact between mother and child.
OTHER	supplemental breast milk	In group two, the newborns receive supplemental breast milk, lying in the arms of a nurse during the heel lance.
OTHER	sucrose	In the third group, newborns receive sucrose 1ml 24% two minutes before procedure, followed by non-nutritive sucking. During the procedure the newborn lies in his cot.

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-08-01
• Completion: 2012-04-01
• First posted: 2011-01-13
• Last updated: 2019-01-17

Locations

1 site across 1 country: Netherlands