Objective: to obtain lung function parameters in infants born preterm at the age of 6 months and to evaluate risk factors for impaired lung function
ID
Source
Brief title
Condition
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: Lung Clearance Index (LCI), airway resistance
(R), functional residual capacity( FRC) and maximal flow at FRC (VmaxFRC)
Secondary outcome
1. Does high LCI at the age of 6 months predict more respiratory symptoms and
hospitalisations due to respiratory problems in the follow up period (first
year of life)?
2. Is het possible to determine perinatal/ neonatal riskfactors for high LCI at
the age of 6 months?
Background summary
Rationale: The NeoLifeS cohort comprises preterm children born before 30 weeks*
gestational age, and /or birth weights below 1000 grams. These children often
have complex health problems after birth and are always treated in a Neonatal
Intensive Care Unit for at least several weeks. Several health problems may
occur in these children during the following years when they grow up, including
respiratory symptoms and impaired lung function. By entering all clinical and
follow-up data from birth onwards into a single database, risk factors for the
health problems might become evident.
Study objective
Objective: to obtain lung function parameters in infants born preterm at the
age of 6 months and to evaluate risk factors for impaired lung function
Study design
Study design: observational study
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: The burden and risks are low. We perform these
tests every week at the pediatric lung function department without
complications. The patient will have to stay several hours more in the hospital
for these lung function tests compared to the patients that only have their
regular follow up visit. A benefit could be that lung function impairment will
be determined very early.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
The NeoLifeS cohort comprises preterm children born before 30 weeks* gestational age, and /or birth weights below 1000 grams.
Exclusion criteria
ill (fever) at the moment of the lung function test
respiratory tract infection
oxygen or feedtubes
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 | NL54534.042.15 |