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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
Sponsor:
Information provided by (Responsible Party):
Gorm Greisen, Rigshospitalet, Denmark

Brief Summary:

Aim

The aim of this study is to determine consequences at school age of the diagnosis of NEC in the neonatal period.

Methods

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.

Primary outcome

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

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Case
Children with a history of necrotizing enterocolitis
control
Children with no history of necrotizing enterocolitis



Primary Outcome Measures :
  1. 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'.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Head circumference [ Time Frame: 5-15 years ]
    Head circumference in cm as measured by parents.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Case-group will include all surviving children born in Denmark between 1st of January 2002 and 31st of December 2011 with an ICD-10 diagnosis of NEC (DP77.9) at discharge.

Matching each child with a history of NEC to two children with no history of NEC by gestational age, year of birth and birthweight will form the control group. Matching criteria's have been chosen to balance prematurity and age at follow-up between case and control-group.

Criteria

Inclusion Criteria case-group:

  • Born from 1st of January 2002 to 31st of December 2011
  • ICD-10 diagnosis of NEC (DP77.9)
  • Survival at follow-up
  • Response to questionnaire

Inclusion Criteria control-group:

  • Born from 1st of January 2002 to 31st of December 2011
  • Matched by year of birth, birthweight and gestational age to children in case-group
  • Survival at follow-up
  • Response to questionnaire

Exclusion Criteria

  • Death before follow-up
  • Non-responders to questionnaire

Information from the National Library of Medicine

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


Locations
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Denmark
Neonatalklinikken, Rigshospitalet
Copenhagen, Capital Region, Denmark, 2100
Department of Neonatology, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Gorm Greisen
Investigators
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Principal Investigator: Gorm Greisen, Professor, MD Rigshospitalet, Denmark

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Responsible Party: Gorm Greisen, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03091907     History of Changes
Other Study ID Numbers: 2012-58-0004
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gorm Greisen, Rigshospitalet, Denmark:
Necrotizing enterocolitis
Followup
Neurodevelopmental impairments
Growth impairments
Gut function
Behavioural impairments
Additional relevant MeSH terms:
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Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases