Status:
COMPLETED
Pain Reactivity to Non-Pharmacological Interventions Across Repeated Routine Heel-Sticks in Preterm Infants in a Neonatal Intensive Care Unit
Lead Sponsor:
University of Basel
Collaborating Sponsors:
University of Pittsburgh
University Hospital, Zürich
Conditions:
Preterm Infants
Eligibility:
All Genders
1-15 years
Phase:
EARLY_PHASE1
Brief Summary
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 e...
Detailed Description
Background and significance: Switzerland with its approximately 8% of premature births is having one of the highest premature rates in Europe and most of the preterm neonates need neonatal intensive ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00758511
Start Date
January 1 2009
End Date
December 1 2009
Last Update
November 15 2013
Active Locations (1)
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1
Institute of Nursing Science Medical Faculty, University of Basel
Basel, Switzerland, 4056