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Observational study.
Metingen naar de functie van de longen bij kinderen van 0 t/m 4 jaar oud: kinderen met CF en gezonde kinderen.



- candidate number2720
- NTR NumberNTR1058
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-sep-2007
- Secondary IDsMEC-2007-193 
- Public TitleObservational study.
Metingen naar de functie van de longen bij kinderen van 0 t/m 4 jaar oud: kinderen met CF en gezonde kinderen.
- Scientific TitleObservational study.
Measurements of pulmonary function in children aged 0 – 4 years: children with CF and healthy controls.
- ACRONYMFLY-study: Function measurements of the Lungs in Young children.
- hypothesisThe measurements of overnight SpO2 and/or gas mixing and/or overnight cough might be useful in CF patients aged 0-4 years old. In this age group, standard spirometry can not (yet) be performed. As a consequence, there currently are no measurements to evaluate effect of treatment or to monitor disease. Therefore we would like to investigate whether these measurements can be useful in the monitoring and treatment of CF.
--- Objectives of this study:
Primary Objective: To measure overnight SpO2, gas mixing and cough in CF patients aged 0-4 years old and in a group of healthy controls of the same age;
Secondary Objective: To investigate whether these measurements can be used in the medical care for young CF patients and /or in medical research.
- Healt Condition(s) or Problem(s) studiedCystic Fibrosis (CF)
- Inclusion criteriaInclusion criteria for children with CF:
1. Age 0 – 4 years (0 up to and including 4 years);
2. Diagnosis of CF confirmed by sweat-test and/or DNA analysis and/or electro physiology testing (nasal potential difference measurement or intestinal current measurement);
3. Clinically stable patients: no hospital admission and no need for an antibiotic course for at least 4 weeks prior to enrolment in the study;
4. No signs of acute viral respiratory infection in the period from 1 week (7 days) before the measurement until the day of the measurement. An acute viral respiratory infection is defined as a combination of the following symptoms: rhinitis; pharyngitis; cough; headache; fever;
5. Signed written informed consent.


Inclusion criteria for healthy children:
1. Age 0-4 years;
2. No use of an antibiotic course (for pulmonary reasons) for at least 4 weeks prior to enrolment in the study;
3. No signs of respiratory infection in the period from 1 week (7 days) before the measurement until the day of the measurement;
4. Signed written informed consent.
- Exclusion criteriaExclusion criteria for children with CF:
1. Medical conditions that might affect the measurements (e.g. cardiac problems that can influence saturation);
2. Pulmonary exacerbation at the time of the study.


Exclusion criteria for healthy children:
1. Medical conditions that might affect the measurements (e.g. cardiac problems that can influence saturation);
2. History of pulmonary diseases such as asthma, BPD, airway malacia;
3. Current use of pulmonary drugs;
4. History of premature birth;
5. ENT related interventions in recent history (< 1 month), such as tonsillectomy, antibiotics for ENT infections, grommets, etc.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-okt-2007
- planned closingdate1-okt-2008
- Target number of participants45
- InterventionsNo interventions, this is an observational study.
- Primary outcomeMeasurements of overnight SpO2, gas mixing and overnight cough.
- Secondary outcome
- Timepoints
- Trial web sitenot applicable
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. E.M. Bakker
- CONTACT for SCIENTIFIC QUERIESDr. H.A.W.M. Tiddens
- Sponsor/Initiator Erasmus Medical Center, Sophia Children’s Hospital, Department of Pediatric Pulmonology
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Sophia Children's Hospital
- Publications1. Kerem, B., et al., Identification of the cystic fibrosis gene: genetic analysis. Science, 1989. 245(4922): p. 1073-80.
2. Armstrong, D.S., et al., Lower respiratory infection and inflammation in infants with newly diagnosed cystic fibrosis. Bmj, 1995. 310(6994): p. 1571-2.
3. Nixon, G.M., et al., Early airway infection, inflammation, and lung function in cystic fibrosis. Arch Dis Child, 2002. 87(4): p. 306-11.
4. Armstrong, D.S., et al., Lower airway inflammation in infants and young children with cystic fibrosis. Am J Respir Crit Care Med, 1997. 156(4 Pt 1): p. 1197-204.
5. Dakin, C.J., et al., Inflammation, infection, and pulmonary function in infants and young children with cystic fibrosis. Am J Respir Crit Care Med, 2002. 165(7): p. 904-10.
6. Gappa, M., S.C. Ranganathan, and J. Stocks, Lung function testing in infants with cystic fibrosis: lessons from the past and future directions. Pediatr Pulmonol, 2001. 32(3): p. 228-45.
7. Stromberg, N.O. and P.M. Gustafsson, Ventilation inhomogeneity assessed by nitrogen washout and ventilation-perfusion mismatch by capnography in stable and induced airway obstruction. Pediatr Pulmonol, 2000. 29(2): p. 94-102.
8. Schibler, A., et al., Moment ratio analysis of multiple breath nitrogen washout in infants with lung disease. Eur Respir J, 2000. 15(6): p. 1094-101.
9. Kraemer, R., et al., Ventilation inhomogeneities in relation to standard lung function in patients with cystic fibrosis. Am J Respir Crit Care Med, 2005. 171(4): p. 371-8.
10. Aurora, P., et al., Multiple breath inert gas washout as a measure of ventilation distribution in children with cystic fibrosis. Thorax, 2004. 59(12): p. 1068-73.
11. Fuchs, S.I., et al., Multiple breath washout with a sidestream ultrasonic flow sensor and mass spectrometry: A comparative study. Pediatr Pulmonol, 2006. 41(12): p. 1218-25.
12. Gustafsson, P.M., Inert gas washout in preschool children. Paediatr Respir Rev, 2005. 6(4): p. 239-45.
13. Tiddens, H.A., Detecting early structural lung damage in cystic fibrosis. Pediatr Pulmonol, 2002. 34(3): p. 228-31.
14. Gustafsson, P.M., P. Aurora, and A. Lindblad, Evaluation of ventilation maldistribution as an early indicator of lung disease in children with cystic fibrosis. Eur Respir J, 2003. 22(6): p. 972-9.
15. Aurora, P., et al., Multiple-breath washout as a marker of lung disease in preschool children with cystic fibrosis. Am J Respir Crit Care Med, 2005. 171(3): p. 249-56.
16. Bush, A. and J. Davies, Early detection of lung disease in preschool children with cystic fibrosis. Curr Opin Pulm Med, 2005. 11(6): p. 534-8.
17. Urschitz, M.S., et al., Reference values for nocturnal home pulse oximetry during sleep in primary school children. Chest, 2003. 123(1): p. 96-101.
18. Gozal, D., Sleep-disordered breathing and school performance in children. Pediatrics, 1998. 102(3 Pt 1): p. 616-20.
19. Beresford, M.W., H. Parry, and N.J. Shaw, Twelve-month prospective study of oxygen saturation measurements among term and preterm infants. J Perinatol, 2005. 25(1): p. 30-2.
20. Frangolias, D.D. and P.G. Wilcox, Predictability of oxygen desaturation during sleep in patients with cystic fibrosis : clinical, spirometric, and exercise parameters. Chest, 2001. 119(2): p. 434-41.
21. Bradley, S., et al., Hypoxemia and hypercapnia during exercise and sleep in patients with cystic fibrosis. Chest, 1999. 116(3): p. 647-54.
22. Berge, M.T., et al., DNase in stable cystic fibrosis infants: a pilot study. J Cyst Fibros, 2003. 2(4): p. 183-8.
23. Chang, A.B., The physiology of cough. Paediatr Respir Rev, 2006. 7(1): p. 2-8.
24. Chang, A.B., et al., Cough quality in children: a comparison of subjective vs. bronchoscopic findings. Respir Res, 2005. 6(1): p. 3.
25. de Jongste, J.C. and M.D. Shields, Cough . 2: Chronic cough in children. Thorax, 2003. 58(11): p. 998-1003.
26. Archer, L.N. and H. Simpson, Night cough counts and diary card scores in asthma. Arch Dis Child, 1985. 60(5): p. 473-4.
27. Falconer, A., C. Oldman, and P. Helms, Poor agreement between reported and recorded nocturnal cough in asthma. Pediatr Pulmonol, 1993. 15(4): p. 209-11.
28. Chang, A.B., et al., Subjective scoring of cough in children: parent-completed vs child-completed diary cards vs an objective method. Eur Respir J, 1998. 11(2): p. 462-6.
29. Urschitz, M.S., et al., Nocturnal arterial oxygen saturation and academic performance in a community sample of children. Pediatrics, 2005. 115(2): p. e204-9.
- Brief summaryRationale: Cystic fibrosis (CF) is the most common inherited disease among the Caucasian population. It is a multisystem disorder, with progressive pulmonary disease accounting for most of the morbidity and mortality. Children with CF develop lower airway infection and inflammation starting in the first months of life. Inflammation and infection lead to structural damage of the lung, which in turn leads to abnormal lung function. To limit damage, early and often aggressive treatment is needed in most children at an early age. Therefore, close monitoring of these young patients is necessary. Measurements of lung function play a central role in the monitoring and management of older children and adults with CF.
However, for children aged 0-4 years, currently used routine lung function tests are cumbersome since active cooperation required for these function tests is mostly not possible. Infant pulmonary function tests have been developed but they are labour intensive, time consuming and require sedation. To develop alternative methods to assess pulmonary disease is especially important in children between 0 and 2 years of age. This age range is characterised by rapid lung growth. Any lung damage is this age range is more likely to have severe long-term adverse effects. There are techniques available that evaluate the condition of the lung and that require a lower level of cooperation. Firstly, a promising new method is the measurement of gas mixing by multiple breath washout, which measures inhomogeneity of ventilation. This is reported as the Lung Clearance Index (LCI). During this 5 – 10 minute procedure children are required to breathe quietly through a facemask or mouthpiece until the measurement has been completed. No active cooperation is required. A second measurement that could be useful is the use of nightly oxygen saturation, measured by pulse oximetry during a normal night of sleep at home. This method is widely used in young children, has been around since more than 20 years but has not been systematically evaluated as a monitoring tool in CF. It has been shown that even in CF patients with moderate lung disease and normal awake oxygen saturation (SpO2,), significant nocturnal desaturation can occur. Thirdly, it is known that cough is one of the most frequent symptoms of CF. Cough is related to mucus and mucociliary clearance. Therefore we are interested in objectively measuring cough in young CF children during a normal night of sleep at home, using a cough audiometer.
Objective: Primary Objective: To measure overnight SpO2, gas mixing and cough in CF patients aged 0-4 years old and in a group of healthy controls of the same age.
Secondary Objective: To investigate whether these measurements can be used in the medical care for young CF patients and /or in medical research.
Study design: This study will be a prospective cross sectional study, and will include approximately 15 children with CF and 30 healthy children.
Study population: Study subjects are children with CF aged 0-4 years and a group of healthy children, with a similar gender and age distribution. All children with CF will be recruited from the outpatient clinic of the pediatric pulmonology department of the Erasmus MC – Sophia Children’s Hospital Rotterdam. Healthy children will be recruited from child day care facilities (for children aged 0 – 3 years) and kindergarten (for children aged 4 years) in Rotterdam.
Main study parameters/endpoints: Gas mixing measured by the Exhalyzer®D. Nightly oxygen saturation measured by the Novametrix Model 2001 MARS pulse oximeter. Nightly cough measured with an audio meter.
- Main changes (audit trail)
- RECORD3-sep-2007 - 3-jul-2010


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