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NCT00926445 Clinical Trial

Neonatal Pain- and Distress Experiences and Later Pain Behavior of Former Preterm and Critically Ill Newborn Infants

Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00926445
Other study ID # 08-177
Secondary ID
Status Recruiting
Phase N/A
First received June 22, 2009
Last updated June 22, 2009
Start date November 2008

Study information
Verified date June 2009
Source University of Cologne
Contact n/a
Is FDA regulated No
Health authority Germany: University of Cologne, ethics committee Cologne
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 7 Days
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Asphyxia

- ICH grade 3 and higher

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Neonatologische Intensivstation Cologne NRW

Sponsors (1)
Lead Sponsor Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

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