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Amphia Premature Infant Pain Study (APIP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Amphia Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Amphia Hospital
ClinicalTrials.gov Identifier:
NCT01276366
First received: April 23, 2010
Last updated: June 21, 2011
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention
Newborns With a Gestational Age of 32-37 Weeks.
Receiving Breast Milk.
Requirement of a Clinical Heel Lance.
 Other: breast feeding
Other: supplemental breast milk
Other: sucrose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Amphia Premature Infant Pain Study; Breast Milk vs Sucrose

Resource links provided by NLM:

Drug Information available for: Sucrose
U.S. FDA Resources

Further study details as provided by Amphia Hospital:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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 [ 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. ] [ Designated as safety issue: No ]
    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. [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    This secondary outcome measure gives us information about the uniformity of the assessment of the films between the three investigators.


Estimated Enrollment: 75
Study Start Date: January 2010
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Other: 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: supplemental breast milk
In group two, the newborns receive supplemental breast milk, lying in the arms of a nurse during the heel lance.
 Other: 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: 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.
 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.

  Eligibility

Ages Eligible for Study:   up to 2 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276366

Locations
Netherlands
Amphia Hospital
Breda, Noord Brabant, Netherlands, 4819 VE
Sponsors and Collaborators
Amphia Hospital
Investigators
Principal Investigator: RHT v Beek, phd Amphia Hospital Breda
  More Information

No publications provided by Amphia Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: dr. R.H.T. van Beek, Amphia Hospital, pediatric department
ClinicalTrials.gov Identifier: NCT01276366     History of Changes
Other Study ID Numbers: NL30111.101.09
Study First Received: April 23, 2010
Last Updated: June 21, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Amphia Hospital:
Heel lance
Premature
Breast milk

ClinicalTrials.gov processed this record on May 22, 2013