- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01276366
Amphia Premature Infant Pain Study (APIP)
Amphia Premature Infant Pain Study; Breast Milk vs Sucrose
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Noord Brabant
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Breda, Noord Brabant, Netherlands, 4819 VE
- Amphia Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
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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: supplemental breast milk
In group two, the newborns receive supplemental breast milk, lying in the arms of a nurse during the heel lance.
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In group two, the newborns receive supplemental breast milk, lying in the arms of a nurse during the heel lance.
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Active Comparator: 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.
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Newborns who are assigned to group one, receive breastfeeding during the blood sample and thereby have skin-skin contact between mother and child.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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The PIPP score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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 .
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The COMFORTneo score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.
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partial correlation between the two pain assessment tools.
Time Frame: up to 2 years
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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.
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up to 2 years
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intra-class correlation coefficient
Time Frame: up to 2 years
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This secondary outcome measure gives us information about the uniformity of the assessment of the films between the three investigators.
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up to 2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: RHT v Beek, phd, Amphia hospital Breda
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL30111.101.09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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