Primary objectives1. What is the pulmonary function and exercise tolerance in children born with esophageal atresia at the age of 8-18 years (group I), determined by spirometry, measurement of lung volumes and a maximal exercise test. 2. What is theā¦
ID
Source
Brief title
Condition
- Gastrointestinal tract disorders congenital
- Gastrointestinal conditions NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Pulmonary function parameters: forced expiratory volume in 1 second (FEV1),
forced vital capacity (FVC), FEV1/FVC ratio, total lung capacity (TLC), vital
capacity (VC), residual volume (RV) and diffusion capacity (DLCO)
2. Maximal exercise test: oxygen saturation, aerobic capacity (VO2 max)
3. Increased risk of gastro-esophageal reflux, based on standardised
questionnaire
3. Health related quality of life, hased on the Child Health Questionnaire.
Secondary outcome
none
Background summary
Children born with esophageal atresia may develop respiratory and
gastro-intestinal complications which are well recognized during the first
years of life. Approximately one third of the patients suffer from severe
gastro-esophageal reflux (GER) and/or tracheamalacie.
However, variable respiratory and gastro-intestinal symptoms may continue into
adolescence and adulthood. In 25-60% of the adult patients, esophagitis was
demonstrated by gastroscopy. In many of these patients with GER a compatible
history was lacking.
Obstructive pulmonary abnormalities have been demonstrated in 10-70% of the
children born with esophageal atresia. Restrictive pulmonary abnormalities have
been described in 18-36% of the patients. Lung function abnormalities may be
secondary to lung damage from recurrent and/or prolonged (micro) aspiration of
gastric contents. It appears that (chronic) GER may also affect tracheamalacia.
It is unknown whether thoracotomy in the neonatal period has adverse effects on
the pulmonary function.
The quality of life of children born with esophageal atresie reaching adulthood
appears to be similar to the healthy population, there are no reports
describing quality of life in childhood survivors of esophageal atresia.
It has been shown that children born with esophageal atresia have more
learning, emotional en behavior problems than in the general population.
Study objective
Primary objectives
1. What is the pulmonary function and exercise tolerance in children born with
esophageal atresia at the age of 8-18 years (group I), determined by
spirometry, measurement of lung volumes and a maximal exercise test.
2. What is the incidence of symptoms due to gastro-esophageal reflux in
children born with an esophageal atresia and in children without an esophageal
atresia but with a history of severe GER.
Secundary objectives
1. What is the pulmonary function and exercise tolerance in children without
esophageal atresia but with a history of severe GER at the age of 8-18 years
(group II), determined by spirometrie, measurement of pulmonary volumes and a
maximal exercise test.
2. Could the pulmonary function abnormalities be the result of the thoracotomy
performed in the neonatal period? This will be determined by comparing the
pulmonary function of children born esophageal atresia and children without
esophageal atresia but with a history of severe GER (group I vs group II).
3. Are there any other factors associated with pulmonary function and maximal
exercise capacity, such as tracheamalacia, duration of ventilation, type of the
esophageal atresia.
4. What is the quality of life of children born with esophageal atresia
5. What is the quality of life of children without esophageal atresia but with
a history of severe GER.
Study design
Observational non-invasive cohort study
Study burden and risks
The burden for the participating patients is low. One visit to the hospital is
necessary. There are no risks involved for the participants.
Currently there is no structured follow-up of these patients, hence it is
likely that children with GER and pulmonary function abnormalities will be
found. Children with abnormalities will be referred to the appropriate
specialist.
postbus 7057
1007 MB Amsterdam
Nederland
postbus 7057
1007 MB Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
age between 8 and 18 years
esophageal atresia OR
surgically treated gastro-esophageal reflux
Exclusion criteria
mental retardation
prematurity (<35 wks)
recognized chronic respiratory diseases (such as cystic fibrosis)
syndromal and/or chromosomal disorders
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 | NL11386.029.06 |