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

• Conditions: Pain

• Registration Number: NCT00926445
• Lead Sponsor: University of Cologne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Status Verified: 2009-06
• Study First Submitted: 2009-06-22
• Study First Submitted QC: 2009-06-22
• Last Update Submitted: 2009-06-22
• Study First Posted: 2009-06-23
• Last Update Posted: 2009-06-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

• Asphyxia
• ICH grade 3 and higher

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Neonatologische Intensivstation; 🇩🇪 Cologne, NRW, Germany