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Comprehensive assessment of the long-term effects of necrotizing enterocolitis and its treatment

Comprehensive assessment of the long-term effects of necrotizing enterocolitis and its treatment - Long-term effects of necrotizing enterocolitis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53387
Enrollment
158
Registered
2023-05-26
Start date
2023-07-26
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vroeggeboorte inflammatory bowel disease intestinal inflammation and injury

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 15 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
This study has two primary endpoints: the between group difference in Short Sensory Profile score and the between-group difference in heat pain sensitivity.

Secondary

MeasureTime frame
In addition, we will assess the between-group differences in heat detection, cold detection, cold pain sensitivity, mechanical detection, mechanical pain sensitivity, behaviour, executive function, chronic pain, and (health-related) quality of life and we will assess cosmetic outcome of and satisfaction with the scar in surgically treated NEC patients.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)