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

University of Cologne

Status: Unknown

Conditions: Pain

Study type: Observational

Funder types: Other

Identifiers

NCT00926445

08-177

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: Under 7 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Asphyxia
• ICH grade 3 and higher

Trial design

120 participants in 3 patient groups

Preterm (BW < 1500 grams)

Critically ill term newborn

Description:

ventilation \> 48 hours

Healthy term newborn