Amphia premature infants painstudy

Only thirty years ago, it was believed that newborns couldn*t feel pain. There
was also a fear for adverse events of treatment with analgesics. Because of
these two reasons, newborns weren*t properly treated for their pain. Now we
know that neonates do feel pain and many research has been performed concerning
the measurement and treatment of pain by newborns.

In this study, we want to find out whether breastfeeding, expressed breastmilk
or sucrose gives better analgesia during a heelstick by premature neonates.

We perform an open-label, randomized controlled trial in Amphia*s hospital in
Breda. Premature neonates were randomly assigned in three groups. Each group
offered another way of analgesic therapy during the heelstick. Group 1 received
breastfeeding during the procedure. Group 2 was given a bottle with expressed
breastmilk by a nurse. And the third group received sucrose two minutes before
the heelstick, lying in a cot.

Breastfed neonates are included in the study when they are born between 32 and
37 weeks gestational age. And when there is a need for a heelstick 24 hours
after birth, in a clinical setting.
The heelstick will be performed with an standardized Infant Heelstick Device.
During the heelstick, newborns of the first group receive breastfeeding. Those
of the second group are given expressed breastmilk by a nurse. And the third
group will be treated with sucrose, lying in a cot. During the procedure, the
investigator will score two pain measurement scales: the PIPP and the
COMFORTneo. The procedure will be recorded and two independent persons will
score the PIPP and the COMFORTneo as well.

Newborns will be observed during a heelstick, which is performed for diagnostic
or screening purposes. Therefore, participation to the study doesnot effect the
number of painful procedures. Since the study exists primarely of an
observation, the burden for the participants is negleciable and no adverse
reactions are expected by participation to the study.