Amphia Premature Infant Pain Study (APIP)

Amphia Hospital

Status

Completed

Conditions

Puncture Skin

Breast Feeding, Exclusive

Premature Infant

Treatments

Other: sucrose

Other: supplemental breast milk

Other: breast feeding

Study type

Interventional

Funder types

Other

Identifiers

NCT01276366

NL30111.101.09

Details and patient eligibility

About

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.

Enrollment

75 patients

Sex

All

Ages

1 day to 2 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

born at a gestational age between 32+0 and 36+6 weeks,
being nourished with breast milk
the necessity for a clinical blood sample.

Exclusion criteria

perinatal asphyxia,
birth trauma,
condition of cardio-respiratory instability,
condition of serious nutritional problems with clinical evidence of gastro oesophageal reflux disease,
drug abuse of the mother
and application of sedative medication to mother or child.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 3 patient groups

sucrose

Active Comparator group

Description:

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.

Treatment:

Other: sucrose

supplemental breast milk

Active Comparator group

Description:

In group two, the newborns receive supplemental breast milk, lying in the arms of a nurse during the heel lance.

Treatment:

Other: supplemental breast milk

Breast feeding

Active Comparator group

Description:

Newborns who are assigned to group one, receive breastfeeding during the blood sample and thereby have skin-skin contact between mother and child.