Main question: What is the lung function of late preterm births compared with children born at term at age 12? Sub-questions: - Which respiratory symptoms in late preterm infants at age 12?
ID
Source
Brief title
Condition
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Spirometry FVC, FEV1, FEV1/FVC, FEF25, FEF50, FEF75,
PEF
Ergometire Heart rate, respiratory rate, maximum load,
VO2rust, maximum respiratory rate, VT, VTmax, VEmax,
ventilatory reserve, VO2 at the
anaerobic threshold (AD), VO2max, AD, AD/VO2, *VO2/*WR, respiratory exchange
ratio,
Borg score
LCI LCI
Secondary outcome
respiratory symptoms due to questionnaire
Background summary
There has been much research into lung problems in extreme preterm infants. A
"forgotten group" is the group of children born between 32 and 35 +6 weeks of
gestation. Research shows that at age 5, these children do indeed have
respiratory symptoms and that they are more often diagnosed with asthma. This
study is to determine the respiratory heath of these children aged 12 years of
age.
Study objective
Main question:
What is the lung function of late preterm births compared with children born at
term at age 12?
Sub-questions:
- Which respiratory symptoms in late preterm infants at age 12?
Study design
Prospective cohort study
Study burden and risks
The risk of participating in the study is very small. The pulmonary function
tests that we use, are used each year in dozens of children without serious
complications .As soon as it turns out that a child is not able to perform the
test, or some other problem occurs , the test will be stopped . According to
European guidelines, lung function measurements , such as spirometry and LCI
are considered risk-free. Provocation tests such as exercise tests are
considered as limited risk .
The research can not be conducted at a different (older) age group , because
the research is specifically designed to detect children at the age of 12 .
However, no pressure will be exerted on the subjects to participate.
With this research we get a better understanding of the extent and nature of
respiratory problems in late preterm infants . The exercise test can thereby
provide clarity about the condition of the child and any physical limitations .
Perhaps treatment methods (and/or follow up of these patients) can be modified
and improved.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Research group
- Born between 32 and 35 +6 weeks of gestation
- From one of the three northern provinces (Drenthe, Groningen and Friesland)
Control group
- Born after 38 weeks gestation
- From one of the three northern provinces (Drenthe, Groningen and Friesland)
Exclusion criteria
Research group
- Duration of pregnancy not precisely determined by ultrasound during pregnancy
- Physical inability to carry out ergometrie test
- Birth Defects
- Illness or fever at the time of measurement
Control group:
- Duration of pregnancy is not exactly determined by ultrasound
- Physical inability to carry out ergometrie test
- Birth Defects
- Use of bronchodilators
- Illness or fever at the time of measurement
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 | NL48410.042.14 |