Amphia Premature Infant Pain Study
This trial is active, not recruiting.
|Conditions||newborns with a gestational age of 32-37 weeks., receiving breast milk., requirement of a clinical heel lance.|
|Treatments||breast feeding, supplemental breast milk, sucrose|
|Start date||January 2010|
|End date||September 2011|
|Trial size||75 participants|
|Trial identifier||NCT01276366, NL30111.101.09|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Pain scores assessed by the PIPP score
time frame: The PIPP score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.
Pain score assessed by the COMFORTneo score
time frame: The COMFORTneo score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.
partial correlation between the two pain assessment tools.
time frame: up to 2 years
intra-class correlation coefficient
time frame: up to 2 years
Male or female participants up to 2 months old.
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.
|Official title||Amphia Premature Infant Pain Study; Breast Milk vs Sucrose|
|Principal investigator||RHT v Beek, phd|
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