Following lung health in babies and toddlers with cystic fibrosis found by newborn screening
Observes how lung disease develops in young children with cystic fibrosis.
Plain-language title generated from the registry record
Registry title: Longitudinal Observational Study on the Course of Cystic Fibrosis Lung Disease in Patients Following Newborn Screening
Key facts
- Where
- Giessen, Hanover, Heidelberg, and Lübeck, GermanySee the 4 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for babies and young children newly diagnosed with cystic fibrosis (CF), either early (in the first 4 months of life) or later because of symptoms.
- Age
- Newly diagnosed in the first 4 months of life (early group) or after the fourth month of life (late group); the diagnosis must have been made after January 1st, 2006.
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed cystic fibrosis. Diagnosis needs at least one of: sweat chloride ≥ 60mEq/L, 2 CF-causing mutations in the CFTR gene, or CF-typical changes in the transepithelial potential difference in nasal or rectal epithelium.
- Biomarker or test result
- Sweat chloride ≥ 60mEq/L and/or 2 CF-causing CFTR gene mutations and/or typical changes in the transepithelial potential difference (at least one of the three).
Main reasons for not taking part
- Born before the 30th week of pregnancy
- Longer mechanical ventilation in the first 3 months of life
- Another significant illness besides CF, or chronic lung disease other than CF (for example bronchopulmonary dysplasia)
- Previous major surgery, except for meconium ileus or atresia of the intestine
- Unsure CF diagnosis, or earlier bad reaction to sedation medicine, or known claustrophobia
Read by machine on 9 November 2026.
Where in Germany
- University Hospital Gießen and Marburg GmbHGiessen, GermanyTaking people
- Medizinische Hochschule HannoverHanover, GermanyTaking people
- University Children's Hospital Heidelberg, Cystic Fibrosis CentreHeidelberg, GermanyTaking people
- University Children's Hospital Schleswig-HolsteinLübeck, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Heidelberg University
- Trial code
- NCT02270476
- Record updated
- 29 November 2023
- Original description
The purpose of this study is to further characterize early CF lung disease in newborns, infants and toddlers with cystic fibrosis (CF).Read full original descriptionShow less
Longitudinal Observational Study on the Course of Cystic Fibrosis Lung Disease in Patients Following Newborn Screening
The purpose of this study is to further characterize early CF lung disease in newborns, infants and toddlers with cystic fibrosis (CF).
Inclusion: Newly diagnosed patients with Cystic Fibrosis (CF). Diagnosis of CF: at least one of the following three international accepted criteria is fulfilled: i) sweat chloride ≥ 60mEq/L and/or ii) 2 CF-causing mutations in the CFTR gene and/or iii) changes typical for CF in the transepithelial potential difference in nasal or rectal epithelium; Age and mode of diagnosis:; Early diagnosed (ED): Initial diagnosis following CF-NBS or for other reasons in the first 4 months of life (in preterms corrected age of 4 months) after January 1st, 2006. Other reasons could be prenatal diagnostics, meconium ileus or positive family history; Late diagnosed (LD): Diagnosed after the fourth month of life due to clinical symptoms; initial diagnosis after January 1st, 2006.
Exclusion: Previous major surgery except for meconium ileus or atresia of the intestine; Severe gastroesophageal reflux, defined as persistent frequent emesis despite anti-reflux therapy; A significant medical disease or condition other than CF likely to interfere with the child's ability to complete the entire protocol; Other major organ dysfunction, excluding pancreatic or hepatic dysfunction or another condition due to CF; Chronic lung disease other than CF (e.g. bronchopulmonary dysplasia); History of adverse reaction to medication for sedation or known claustrophobia; Criteria, which lead to a displacement of the procedures in sedation until the child has recovered: - Clinically significant upper airway obstruction as determined by investigator (e.g; severe laryngomalacia, markedly enlarged tonsils, significant snoring, diagnosed obstructive sleep apnoea); All patients are excluded who themselves or whose parents do not want to participate or that withdraw from the study; or those in whom the diagnosis of CF is unsure; Further exclusion criteria are:; Preterms <30th week of gestation; Longer period of mechanical ventilation in first 3 months of life; Physical findings that would compromise the safety of the subject or the quality of the study data as determined by investigator.