Overview

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
Sponsor Amphia Hospital
Start date January 2010
End date September 2011
Trial size 75 participants
Trial identifier NCT01276366, NL30111.101.09

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.
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.
(Active Comparator)
In group two, the newborns receive supplemental breast milk, lying in the arms of a nurse during the heel lance.
supplemental breast milk
In group two, the newborns receive supplemental breast milk, lying in the arms of a nurse during the heel lance.
(Active Comparator)
Newborns who are assigned to group one, receive breastfeeding during the blood sample and thereby have skin-skin contact between mother and child.
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.

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
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

Eligibility Criteria

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.

Additional Information

Official title Amphia Premature Infant Pain Study; Breast Milk vs Sucrose
Principal investigator RHT v Beek, phd
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by Amphia Hospital.