NCT00503100

Brief Summary

Background: Several studies have indicated that infants who had undergone postnatal painful procedures appear to be hypersensitive to pain, with a lower threshold to tactile stimulations later on life. Objective: To study the effect of early exposure to pain on cerebral somatosensory evoked potential (SEP) response to thermal stimulation (550C), in preterm and full term born adolescents (15-18 years old), who have undergone painful procedures during their neonatal period. As well as to study the effect of early exposure to thermal and tactile sensory thresholds and pain thresholds to thermal and tactile stimuli, by using the TSA and von Frey hairs. Design: Case-control study. Participants: Four groups of 20 adolescents (aged 15-18 years), two of which are full term and preterm-born who were exposed to painful procedures during the neonatal period. The other two groups are term and preterm-born adolescents who were not exposed to such procedures. Main Outcome Measures: Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C). Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer (TSA-2001,Medoc Ltd., Israel). Pain threshold to tactile stimulation will be measured by using Von-Frey hairs.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

May 21, 2015

Status Verified

May 1, 2015

Enrollment Period

6.4 years

First QC Date

July 17, 2007

Last Update Submit

May 20, 2015

Conditions

Somatosensory Disorders

Keywords

PainPreterm-Born Adolescents

Outcome Measures

Primary Outcomes (1)

  • Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C).

    During the test

Secondary Outcomes (2)

  • Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer (TSA-2001,Medoc Ltd., Israel).

    At time of the test

  • Pain threshold to tactile stimulation will be measured by using Von-Frey hairs

    At time of the test

Study Arms (4)

NICU full-term early pain group

Device: Thermal stimulation

NICU premature early pain group

Device: Thermal stimulation

NICU premature control group

Device: Thermal stimulation

Soroka- full-term control group

Device: Thermal stimulation

Interventions

Thermal stimulationDEVICE

Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C). Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer (TSA-2001,Medoc Ltd., Israel). Pain threshold to tactile stimulation will be measured by using Von-Frey hairs.

NICU full-term early pain groupNICU premature control groupNICU premature early pain groupSoroka- full-term control group

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Four groups of 20 adolescents (aged 14 years or older), two of which are full term and preterm-born who were exposed to painful procedures during the neonatal period. The other two groups are term and preterm-born adolescents who were not exposed to such procedures.

You may qualify if:

  • For all:
  • Age 15-18
  • Appropriate weight for gestational age (AGA)
  • Informed consent signed by the parent
  • Presence of one parent during the examination
  • Premature groups:
  • Preterm-born (32-34 weeks of gestation)
  • Admitted to the NICU (ventilated vs. non-ventilated)
  • Full term groups:
  • Completed 37 weeks of gestation Pain groups (premature and full term)
  • Admitted to the NICU
  • Mechanically-ventilated during the first week of life
  • Mechanically-ventilated for at least 48 hours

You may not qualify if:

  • Current use of analgesia
  • A chronic illness with current medical treatment
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ben Gurion University of the Negev, Siaal research center for family medicine and primary care

Beersheba, 84105, Israel

Location

MeSH Terms

Conditions

Somatosensory DisordersPain

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pesach Shvartzman, MD

    Ben-Gurion University of the Negev

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Department of Family Medicine

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 18, 2007

Study Start

August 1, 2007

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

May 21, 2015

Record last verified: 2015-05

Locations

IL(1)