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Clinical Trials/NCT00926445
NCT00926445
Unknown
Not Applicable

Effect of Neonatal Pain- and Distress Experiences on Later Pain Behaviour of Former Preterm and Critically Ill Newborn Infants

University of Cologne1 site in 1 country120 target enrollmentNovember 2008
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
University of Cologne
Enrollment
120
Locations
1
Last Updated
16 years ago

Overview

Brief Summary

Preterm and critically ill neonates experience many painful manipulations. The aim of the study is to evaluate the influence of these experiences and maternal deprivation on later pain behavior. Using Scoring systems, Prechtl general movements, skin conductance, testing flexor reflex levels with von Frey filaments and measuring salivary cortisol levels the investigators compare pain behavior of preterm (birth weight (BW) < 1500 grams), term neonates with need of ventilation (> 48 hours) with healthy neonates at the time of their first vaccination at the age of 3-4 months. The investigators are also testing flexor reflexes and skin conductance and general movements in regular intervals during the initial hospital stay. The investigators hypothesize that pain behavior is different at the age of 3-4 months in children with many early painful experiences.

Registry
clinicaltrials.gov
Start Date
November 2008
End Date
TBD
Last Updated
16 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Preterm \< 1500 grams BW, critically ill term newborn on ventilation \> 48 hours

Exclusion Criteria

  • ICH grade 3 and higher

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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