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The effects of birth after 32-36 weeks of pregnancy on the lung function of children at the age of 12


- candidate number16593
- NTR NumberNTR4567
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-mrt-2014
- Secondary IDsnot yet available 
- Public TitleThe effects of birth after 32-36 weeks of pregnancy on the lung function of children at the age of 12
- Scientific TitleThe effects of birth after 32-36 weeks of pregnancy on the lung function of children at the age of 12
- ACRONYMFollow up study PINKELTJE-cohort
- hypothesisThe hypothesis is that modarate and late preterm infants at age 12 reported more symptoms consistent with asthma and use more asthma medications, as well as a poorer lung function, exercise capacity and Lung Clearance Index than healthy peers.
- Healt Condition(s) or Problem(s) studiedPrematurity, Asthma, Excercise capacity, Lung function
- Inclusion criteriaResearch group
- Born between 32 and 36 +6 weeks of gestation
- From one of the three northern provinces (Drenthe, Groningen and Friesland)

Control group
- Born after 37 weeks gestation
- From one of the three northern provinces (Drenthe, Groningen and Friesland)
- Exclusion criteriaResearch group
- Duration of pregnancy precisely determined by ultrasound
- Physical inability to carry out fietsergometrietest
- 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 fietsergometrietest
- Birth Defects
- Use of bronchodilators
- Illness or fever at the time of measurement
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2014
- planned closingdate1-sep-2015
- Target number of participants80
- InterventionsQuestionnaires (general, ISAAC, PAQ C)
Ergometrie
Spirometrie
Lung Clearance Index
- Primary outcomeSpirometrie : FVC, FEV1, FEV1/FVC, FEF25, FEF50, FEF75, PEF

Ergometire : Hartfrequentie, ademhalingsfrequentie, maximalebelasting, VO2rust, maximale ademfrequentie, VT, VTmax, VEmax, ventilatoire reserve, VO2 op de anaerobe drempel (AD), VO2max, AD, AD/VO2, ΔVO2/ΔWR, respiratory exchange ratio, Borg score

LCI : LCI, Scon, Salv
- Secondary outcomeno
- TimepointsMarch 2014: authorization procedure Metc
September 2014: Sending information letters to parents
September 2015- January 2015: Planning and performing measurements
January 2015: analyze data
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. E.J.L.E. Vrijlandt
- CONTACT for SCIENTIFIC QUERIESDr. E.J.L.E. Vrijlandt
- Sponsor/Initiator University Medical Center Groningen (UMCG), Beatrix Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Stichting AstmaBestrijding (SAB)
- Publications
- Brief summaryThere has been much research into lung problems in extremely preterm children. A "forgotten group" is the group of children born between 32 and 36 weeks gestation. Research shows that at age 5, these children do indeed have respiratory symptoms, and report a doctor's diagnosis of asthma more often. This study is to determine how these children are at the age of 12 in the respiratory field. To investigate this, we use questionnaires, LCI, spirometry and exercise testing.
- Main changes (audit trail)
- RECORD2-mrt-2014 - 1-jun-2014


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