Long-term Consequences of Necrotizing Enterocolitis in the Newborn Period

NCT03091907 | Completed

• 1 other identifier: 2012-58-0004
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

NEC - Necrotizing Enterocolitis; Complications

Keywords

Necrotizing enterocolitis; Followup; Neurodevelopmental impairments; Growth impairments; Gut function; Behavioural impairments

Outcome Measures

Primary Outcomes (1)

• Behavioral impairments

  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'.

  6-15 years

Secondary Outcomes (6)

• Cerebral palsy

  5-15 years

• Height

  5-15 years

• Head circumference

  5-15 years

• Absence from school due to abdominal symptoms

  5-15 years

• Constipation

  5-15 years

Study Arms (2)

Case

Children with a history of necrotizing enterocolitis

control

Children with no history of necrotizing enterocolitis

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gorm Greisen: lead

Study Sites (2)

Neonatalklinikken, Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Location

Department of Neonatology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Gorm Greisen, Professor, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: August 5, 2017
• Primary Completion: January 1, 2018
• Study Completion: August 1, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)