The 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…
ID
Bron
Verkorte titel
Aandoening
Cystic fibrosis, CF.
Ondersteuning
and
ms. E.M. Bakker, M.D.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Measurements of overnight SpO2, gas mixing and overnight cough.
Achtergrond van het onderzoek
Rationale: 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.
Doel van het onderzoek
The 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.
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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.
Onderzoeksproduct en/of interventie
No interventions, this is an observational study.
Publiek
Dr. Molenwaterplein 60
E.M. Bakker
Dr. Molenwaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636683
e.bakker@erasmusmc.nl
Wetenschappelijk
Dr. Molenwaterplein 60
E.M. Bakker
Dr. Molenwaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636683
e.bakker@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Inclusion 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Exclusion 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.
Opzet
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1026 |
| NTR-old | NTR1058 |
| Ander register | : MEC-2007-193 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
Samenvatting resultaten
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