An interventional study of breast feeding and supplemental breast milk in Premature Infant, Breast Feeding, Exclusive and Puncture Skin, sponsored by Amphia Hospital. Completed at 1 site in Netherlands. Open to participants aged 1 Day to 2 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-17.
Sponsored by Amphia Hospital · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Other: sucrose
In group two, the newborns receive supplemental breast milk, lying in the arms of a nurse during the heel lance.
Other: supplemental breast milk
Newborns who are assigned to group one, receive breastfeeding during the blood sample and thereby have skin-skin contact between mother and child.
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.
In group two, the newborns receive supplemental breast milk, lying in the arms of a nurse during the heel lance.
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.
Pain scores assessed by the PIPP score
The primary outcome in this trial is the PIPP-score.The PIPP-score is a multidimensional pain assessment measure developed in 1995 . The PIPP-score is validated for procedural and post-operative pain in premature and term newborns.
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
The COMFORTneo is a secondary outcome.The COMFORTneo is a pain assessment measure modified from the COMFORT behaviour scale. In 2009 the COMFORTneo is validated for prolonged pain. The COMFORTneo is not validated for procedural pain yet .
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.
A secondary outcome is the partial correlation between the PIPP-score and the COMFORTneo score for a heellance in babies born with a postconceptional age between 32 and 37 weeks. When all films are observed, the COMFORTneo scores and PIPP scores are evaluated. We measure a partial correlation coefficient between these scores, to compare these two scores.
Time frame: up to 2 years
intra-class correlation coefficient
This secondary outcome measure gives us information about the uniformity of the assessment of the films between the three investigators.
Time frame: up to 2 years
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Amphia Hospital