Research of lung function and exercise capacity in late preterms (32-36 weeks gestation) in comparison with term born controls of 8 years
ID
Source
Brief title
Condition
- Congenital respiratory tract disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Spirometry: FEV1,
Total lung capacity: RV/%TLC,
diffusion capacity: Dlco,
nitrogen monoxide: FeNO
provocation test: PD20 metacholine
exercise test: VO2 max.
Secondary outcome
Spirometry: FVC, FEV1/FVC, FEF25, FEF50, FEF75, PEF
Total lung capacity: TLC, TGV, RV , Raw, sGaw
diffusion capacity: DLco va, Kco
resistance measure: Rrs6
exercise test: Heart rate max, heart rate reserve, breathing frequency, maximal
load, VO2 rest, breathing frequency, VT , VTmax, VEmax, ventilatory reserve,
VO2 at AT, VO2max, AT, AT/ VO2, ΔVO2/ ΔWR, respiratory exchange ration, borg
score
-for comparison of the RSV admitted children with the non-RSV-admitted children
the same studyparameters will be used.
-Sensibility, specifity and ROC-curves will be calculated to determine the most
discriminative test
Background summary
Preterm children (<32 weeks gestation) have more respiratory complaints and
more abnormalities in lung function tests compared to term born children.
Little is known about lung function and exercise capacity in children born in
32-36 weeks gestation, the so called "late" preterms.
The last stage of lung development (alveolarisation) begins around 32-36 weeks
gestation. When a child is born before or during this stage, problems could
arise in: alveolarisation, vascularisation and/or damage by treatment. Children
hospitalized due to Respiratory Syncitial Virus suffer chronic respiratory
morbidity. The RS-hospitalized preterm children are at very high risk for such
an adverse outcome. Therefor they are invited as a seperate group.
Study objective
Research of lung function and exercise capacity in late preterms (32-36 weeks
gestation) in comparison with term born controls of 8 years
Study design
cross-sectional research design
The lung function testing contains: spirometry, diffusion capacity, total lung
capacity, a resistance measure with a forced oscillation technique, nitrogen
monoxide in the expired air, an exercise test and a provocation test with
metacholine.
Intervention
an exercise test and a provocation test with metacholine
Study burden and risks
The burden associated with participation is due to the lung function tests,
particularly the bronchial challenge test. Each lung function test takes about
20-30 minutes and asks active cooperation of the participant. However
metacholine could provoke bronchoconstriction, or narrowing of the airways.
People with pre-existing airway hyperreactivity, such as asthmatics, will react
to lower doses of metacholine compared to controls who will not react. The
degree of narrowing can then be quantified by spirometry. A bronchodilator
(salbutamol) is administered to counteract the effects of the
bronchoconstrictor. In the exercise test participants will be asked to
continue as long as possible. Most children see this as a challenge. The risk
of these tests is very small. Each year these tests are performed by many
children without serious complications. According to European guidelines lung
function tests like spirometry and NO measures are seen as riskless.
Provocation tests like an exercise test and metacholine challenge are seen as
tests with a limited risk.
Hanzeplein 1
9713 GZ Groningen
Nederland
Hanzeplein 1
9713 GZ Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Late Preterms: 40 children of the 'Pinkeltje' cohort with pregnancy duration 32-36 weeks.
Term born children: 40 children of the 'Pinkeltje' cohort with pregnancy duration 38-41 weeks.
All living in Friesland, Groningen or Drenthe.
All children from the 'Pinkeltje' cohort who are hospitalised because of RSV (n=39)
Exclusion criteria
Children with major congenital abnormalities
Children who are not able to perform a lung function test and/or an exercise test
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 | NL27026.000.10 |