Amphia Premature Infant Pain Study (APIP)
Primary Purpose
Premature Infant, Breast Feeding, Exclusive, Puncture Skin
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
breast feeding
supplemental breast milk
sucrose
Sponsored by

About this trial
This is an interventional treatment trial for Premature Infant focused on measuring Heel lance, Premature, Breast milk
Eligibility Criteria
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.
Sites / Locations
- Amphia Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
sucrose
supplemental breast milk
Breast feeding
Arm 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.
In group two, the newborns receive supplemental breast milk, lying in the arms of a nurse during the heel lance.
Newborns who are assigned to group one, receive breastfeeding during the blood sample and thereby have skin-skin contact between mother and child.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 .
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.
intra-class correlation coefficient
This secondary outcome measure gives us information about the uniformity of the assessment of the films between the three investigators.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01276366
Brief Title
Amphia Premature Infant Pain Study
Acronym
APIP
Official Title
Amphia Premature Infant Pain Study; Breast Milk vs Sucrose
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2010 (undefined)
Primary Completion Date
August 1, 2011 (Actual)
Study Completion Date
April 1, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amphia Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infant, Breast Feeding, Exclusive, Puncture Skin
Keywords
Heel lance, Premature, Breast milk
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sucrose
Arm Type
Active Comparator
Arm 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.
Arm Title
supplemental breast milk
Arm Type
Active Comparator
Arm Description
In group two, the newborns receive supplemental breast milk, lying in the arms of a nurse during the heel lance.
Arm Title
Breast feeding
Arm Type
Active Comparator
Arm Description
Newborns who are assigned to group one, receive breastfeeding during the blood sample and thereby have skin-skin contact between mother and child.
Intervention Type
Other
Intervention Name(s)
breast feeding
Intervention Description
Newborns who are assigned to group one, receive breastfeeding during the blood sample and thereby have skin-skin contact between mother and child.
Intervention Type
Other
Intervention Name(s)
supplemental breast milk
Intervention Description
In group two, the newborns receive supplemental breast milk, lying in the arms of a nurse during the heel lance.
Intervention Type
Other
Intervention Name(s)
sucrose
Intervention 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.
Primary Outcome Measure Information:
Title
Pain scores assessed by the PIPP score
Description
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.
Secondary Outcome Measure Information:
Title
Pain score assessed by the COMFORTneo score
Description
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.
Title
partial correlation between the two pain assessment tools.
Description
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
Title
intra-class correlation coefficient
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RHT v Beek, phd
Organizational Affiliation
Amphia Hospital Breda
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amphia Hospital
City
Breda
State/Province
Noord Brabant
ZIP/Postal Code
4819 VE
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
22392168
Citation
Simonse E, Mulder PG, van Beek RH. Analgesic effect of breast milk versus sucrose for analgesia during heel lance in late preterm infants. Pediatrics. 2012 Apr;129(4):657-63. doi: 10.1542/peds.2011-2173. Epub 2012 Mar 5.
Results Reference
derived
Learn more about this trial
Amphia Premature Infant Pain Study
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