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

NCT00926445 | Unknown

• 1 other identifier: 08-177
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pain behavior

Study Arms (3)

Preterm (BW < 1500 grams)

Critically ill term newborn

ventilation \> 48 hours

Healthy term newborn

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Premature, critically ill term infants are recruited from the NICU of the University hospital of Cologne. Healthy newborns are recruited from the nursery of the University hospital of Cologne.

You may qualify if:

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

You may not qualify if:

• Asphyxia
• ICH grade 3 and higher

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

Neonatologische Intensivstation

Cologne, North Rhine-Westphalia, 50931, Germany

RECRUITING

Biospecimen

Saliva for measuring cortisol levels

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 22, 2009
• First Posted: June 23, 2009
• Study Start: November 1, 2008
• Last Updated: June 23, 2009

Record last verified: 2009-06

Locations

DE (1)