To evaluate the bowel function, quality of life and nutritional status in adolescents/adults who experienced an episode of NEC at neonatal age.
ID
Source
Brief title
Condition
- Gastrointestinal signs and symptoms
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Bowel function at adolescent/adult age as measured by a questionnaire developed
and validated in our center.
Secondary outcome
The secondary study parameters are nutritional status, prevalence of irritable
bowel syndrome (IBS), quality of life, and bone mineral density.
Background summary
Neonatal Necrotizing enterocolitis (NEC) is a gastrointestinal disease mainly
affecting premature neonates with a relatively high mortality and morbidity.
The literature suggests some deficiencies in vitamin status and bone mineral
density associated with intestinal diseases. To date, no information is
available regarding the quality of life, bowel function, bone mineral density,
and nutritional status in the adolescent/adult age.
Study objective
To evaluate the bowel function, quality of life and nutritional status in
adolescents/adults who experienced an episode of NEC at neonatal age.
Study design
Single centre, prospective, descriptive cohort study.
Study burden and risks
Subjects will have the benefit of having their intestinal function, blood
parameters (vitamin status etc), and bone mineral density evaluated. The
expected burden for the participants is negligible. Patients are asked to fill
in questionnaires regarding functional bowel symptoms, IBS symptoms, quality of
life and to fill in dietary records (both groups). They are also asked to visit
the outpatient clinic for a nutritional status assessment, blood sampling, and
a DEXA scan.
Postbus 2060, kamer Sk-1268
3000 CB Rotterdam
NL
Postbus 2060, kamer Sk-1268
3000 CB Rotterdam
NL
Listed location countries
Age
Inclusion criteria
NEC group: Adolescents/adults with episode of NEC at neonatal age, treated conservatively or surgically in the period January 1, 1980 and December 31, 1995, and informed consent.
Exclusion criteria
Unable to complete the questionnaire.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL35786.078.11 |