Long-term Consequences of Necrotizing Enterocolitis in the Newborn Period
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|ClinicalTrials.gov Identifier: NCT03091907|
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : December 5, 2018
The aim of this study is to determine consequences at school age of the diagnosis of NEC in the neonatal period.
This is a case-control study, with case-group being children born in Denmark with a history of NEC and control-group being age-, gestational age- and year of birth matched children born in Denmark with no history of NEC.
Abnormal or borderline 'total difficulties score' in the strenghts-and-difficulties-questionnaire as assessed by parents.
|Condition or disease|
|NEC - Necrotizing Enterocolitis Complications|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||400 participants|
|Official Title:||Long-term Consequences of Necrotizing Enterocolitis in the Newborn Period: Follow-up at School Age, a Case-control Study|
|Actual Study Start Date :||August 5, 2017|
|Actual Primary Completion Date :||January 1, 2018|
|Actual Study Completion Date :||August 1, 2018|
Children with a history of necrotizing enterocolitis
Children with no history of necrotizing enterocolitis
- Behavioral impairments [ Time Frame: 6-15 years ]Strength and Difficulties Questionnaire (SDQ). Behavioral impairment (yes/no) is defined if the child has an abnormal or borderline score for the 'total difficulties score'.
- Cerebral palsy [ Time Frame: 5-15 years ]We will dichotomize between non/mild cerebral palsy defined as lower score than III in the Gross Motor Function Classification System and moderate/severe cerebral palsy defined as scoring III or higher.
- Height [ Time Frame: 5-15 years ]Height in cm as measured by parents. 'low height-for-age' defined as height in cm less than - 2 standard deviations.
- Head circumference [ Time Frame: 5-15 years ]Head circumference in cm as measured by parents.
- Absence from school due to abdominal symptoms [ Time Frame: 5-15 years ]Defined as number of days within the last six months, where the child has stayed home from school due to abdominal symptoms including pain, diarrhea, constipation, frequent bowel movements etc.
- Constipation [ Time Frame: 5-15 years ]Defined as wether or not the child, within the last six months, have had stools scoring 1 or 2 on the Bristol Stool Scale.
- Diarrhoea [ Time Frame: 5-15 years ]Defined as wether or not the child, within the last six months, have had stools scoring 5-7 on the Bristol Stool Scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091907
|Copenhagen, Capital Region, Denmark, 2100|
|Department of Neonatology, Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Gorm Greisen, Professor, MD||Rigshospitalet, Denmark|