Comprehensive assessment of the long-term effects of necrotizing enterocolitis and its treatment
- Conditions
- vroeggeboorteinflammatory bowel diseaseintestinal inflammation and injury10017969
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 158
NEC group: Preterm born children treated (surgically or conservatively) for
necrotizing enterocolitis Bell*s stage II or III in the Erasmus MC-Sophia
Children*s Hospital after January 1, 2008; Corrected age 6-15 years; Informed
consent from parents/caregivers
Control group: Preterm born children admitted to the NICU of the Erasmus MC -
Sophia Children*s Hospital after January 1, 2008; Corrected age 6-15 years;
Informed consent from parents/caregivers
NEC group: Focal intestinal perforation solely instead of NEC; Insufficient
understanding of the Dutch or English language; Severe intellectual disability
(defined as unable to cooperate in the performed tests); Severe motor
disability (defined as unable to determine the child*s reaction time prior to
the thermal sensitivity assessment)
Control group: In addition to the exclusion criteria mentioned above, diagnosis
of necrotizing enterocolitis
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>This study has two primary endpoints: the between group difference in Short<br /><br>Sensory Profile score and the between-group difference in heat pain<br /><br>sensitivity. </p><br>
- Secondary Outcome Measures
Name Time Method <p>In addition, we will assess the between-group differences in heat detection,<br /><br>cold detection, cold pain sensitivity, mechanical detection, mechanical pain<br /><br>sensitivity, behaviour, executive function, chronic pain, and (health-related)<br /><br>quality of life and we will assess cosmetic outcome of and satisfaction with<br /><br>the scar in surgically treated NEC patients.</p><br>