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Pain Reactivity to Non-Pharmacological Interventions Across Repeated Routine Heel-Sticks in Preterm Infants in a Neonatal Intensive Care Unit (PAMINA)

This study has been completed.
Sponsor:
Collaborators:
University of Pittsburgh
University Hospital, Zürich
University Hospital Inselspital, Berne
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00758511
First received: September 23, 2008
Last updated: February 18, 2010
Last verified: February 2010
History of Changes
  Purpose

Switzerland is having one of the highest premature rates in Europa and most of the preterm neonates need neonatal intensive care. Up to 80% of the analgesic used in neonatal intensive care units are either "off label used" or "non-licensed" used. As an alternative approach non-pharmacological interventions for pain prevention and relief are increasingly being recommended for the prevention and treatment of mild and moderate pain in this population.

This multicenter pilot study will use a randomized three group,repeated measures design.

The primary aims of this study of premature neonates are to:

1.) Estimate effect sizes for the impact of the proposed interventions(facilitated tucking alone, sucrose alone and sucrose in combination with tucking)on pain reactivity.

2.) Examine the impact of gestational age on the estimates of efficacy 3.) Examine the impact of the numbers of painful procedures the infant experiences and the concurrent use of analgesic medications on the estimates of efficacy


Condition Intervention Phase
Preterm Infants
 Procedure: 25% Sucrose
Procedure: facilitated tucking
Procedure: Sucrose and facilitated tucking
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pain Reactivity to Non-pharmacological Interventions Across Repeated Routine Heel-Sticks in Preterm Infants in a Neonatal Intensive Care Unit

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
Drug Information available for: Sucrose
U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Pain reaction [ Time Frame: first 14 days of life ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: January 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Orally administrated 25%sucrose before,during and after heel stick across 5 heel sticks during the first 14 days of postnatal life
 Procedure: 25% Sucrose
orally administrated 25%Sucrose before, during and after heel stick
Active Comparator: 2
facilitated tucking before, during and after heel stick across 5 heel stick during the first 14 days of postnatal life
 Procedure: facilitated tucking
facilitated tucking before, during and after heel stick
Active Comparator: 3
orally administrated 25% sucrose AND facilitated tucking before, during and after heel stick across 5 heel sticks during the first 14 days of postnatal life
 Procedure: Sucrose and facilitated tucking
orally administrated 25%sucrose and facilitated tucking before, during and after heel stick

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 15 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • must be born between 24 0/7 and 32 0/7 weeks of gestation
  • must be hospitalized in the NICU
  • it must be anticipated that they will need at least 5 routine heel sticks
  • their parents give informed consent

Exclusion Criteria:

had a high-grade intraventricular hemorrhaging (grade III and IV);

  • have a severe, life-threatening malformations;
  • are suffering from any condition involving partial or total loss of sensitivity
  • had a pHa < 7.00;
  • had surgery for any reason; or
  • have a congenital malformation affecting brain circulation or the cardiovascular system.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758511

Locations
Switzerland
Institute of Nursing Science Medical Faculty, University of Basel
Basel, Switzerland, 4056
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University of Pittsburgh
University Hospital, Zürich
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Eva EC Cignacco, PhD,MNSc, RM Institute of Nursing Science, medical Faculty, University of Basel
  More Information

No publications provided

Responsible Party: Cignacco Eva,PhD,MNSc,RM, Institute of Nursing Science, Medical Faculty, University of Basel
ClinicalTrials.gov Identifier: NCT00758511     History of Changes
Other Study ID Numbers: 3200B1_122676, 3200B1_122676
Study First Received: September 23, 2008
Last Updated: February 18, 2010
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
cortisol
pain
pain management
 preterm infants
sucrose
facilitated tucking

ClinicalTrials.gov processed this record on May 19, 2013