Overview/Definition

Definition:
-• Cystic fibrosis (CF) is an autosomal recessive genetic disorder caused by mutations in the CFTR gene, resulting in defective chloride transport and multisystem disease affecting primarily lungs, pancreas, and digestive system
-Life-limiting condition requiring early diagnosis through newborn screening and comprehensive multidisciplinary management including novel CFTR modulator therapies.
Epidemiology:
-• Incidence varies by ethnicity: 1 in 3,500 births in Caucasians, 1 in 15,000 in African Americans, 1 in 100,000 in Asian populations
-In India, estimated incidence 1 in 40,000-100,000 births with under-diagnosis due to lack of universal screening
-Carrier frequency approximately 1 in 25 in Caucasian populations.
Age Distribution:
-• Symptoms can present at any age but majority diagnosed in first year of life through newborn screening programs
-Classic presentation includes meconium ileus (15-20% of newborns), failure to thrive, recurrent respiratory infections, and pancreatic insufficiency
-Late diagnosis possible with milder mutations or atypical presentations.
Clinical Significance:
-• Critical high-yield topic for DNB Pediatrics and NEET SS examinations focusing on screening protocols, genetic counseling, comprehensive care, and breakthrough CFTR modulator therapies
-Essential for understanding precision medicine approaches, multidisciplinary care coordination, and family-centered chronic disease management in pediatric practice.

Age-Specific Considerations

Newborn:
-• Newborn screening using immunoreactive trypsinogen (IRT) identifies most CF cases before symptoms develop
-Meconium ileus present in 15-20% of CF newborns requiring immediate surgical consultation
-Pancreatic insufficiency present in 85-90% from birth requiring enzyme replacement
-Early nutritional optimization critical for long-term outcomes.
Infant:
-• Peak age for CF diagnosis through screening follow-up or symptomatic presentation
-Failure to thrive, chronic cough, recurrent respiratory infections, and bulky stools common presentations
-Airway clearance techniques adapted for infants
-Nutritional requirements 120-150% of normal due to malabsorption
-Growth velocity monitoring essential.
Child:
-• School-age children require intensive daily management including airway clearance, medications, and nutritional support
-Pulmonary function testing becomes possible for monitoring disease progression
-Chronic colonization with CF-specific pathogens develops
-Social challenges including treatment burden, school absences, and peer relationships.
Adolescent:
-• Transition period with increased responsibility for self-management and treatment adherence challenges
-CFTR modulators may be available based on genotype
-Fertility counseling important as males typically infertile
-Preparation for adult care transition
-Psychosocial support crucial for adaptation to chronic illness.

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Clinical Presentation

Symptoms:
-• Respiratory: chronic productive cough, recurrent pneumonia, persistent sinus congestion, nasal polyps
-Gastrointestinal: bulky greasy stools, poor weight gain despite good appetite, rectal prolapse, salt loss syndrome
-Neonates: meconium ileus, prolonged jaundice, failure to pass meconium within 24-48 hours.
Physical Signs:
-• Growth parameters: poor weight gain and linear growth despite adequate caloric intake
-Respiratory: digital clubbing, hyperinflated chest, adventitious sounds on auscultation
-Abdominal: distension, hepatomegaly from fatty infiltration
-Salty taste to skin, excessive salt crystals on skin surface.
Severity Assessment:
-• Mild CF: minimal respiratory symptoms, pancreatic sufficient (10-15% of patients), normal or near-normal growth
-Moderate CF: chronic respiratory symptoms, pancreatic insufficient, some growth impairment, intermittent exacerbations
-Severe CF: significant respiratory disease, severe malnutrition, frequent hospitalizations, multi-organ complications.
Differential Diagnosis:
-• Primary ciliary dyskinesia (PCD), immunodeficiency disorders, asthma with growth failure, chronic sinusitis, bronchiectasis from other causes, pancreatic insufficiency from other etiologies, celiac disease, inflammatory bowel disease
-Sweat test and genetic testing differentiate CF from mimicking conditions.

Diagnostic Approach

History Taking:
-• Detailed family history including consanguinity, unexplained infant deaths, chronic respiratory or gastrointestinal symptoms in relatives
-Birth history including meconium ileus or delayed passage of meconium
-Growth pattern assessment from birth
-Recurrent infection history and hospitalization patterns.
Investigations:
-• Newborn screening: elevated IRT (>99.9th percentile) prompts genetic analysis or repeat IRT
-Sweat chloride test: gold standard with levels ≥60 mEq/L diagnostic, 30-59 mEq/L intermediate, <30 mEq/L normal
-Genetic testing: identifies CFTR mutations and guides therapy
-Comprehensive CFTR genetic analysis if clinical suspicion high.
Normal Values:
-• Normal IRT levels <99th percentile for age (typically <70 ng/mL in first 48 hours)
-Normal sweat chloride <30 mEq/L, intermediate 30-59 mEq/L, abnormal ≥60 mEq/L
-Adequate sweat collection requires >75 mg (>15 mg in newborns)
-Normal pancreatic elastase >200 mcg/g stool indicates pancreatic sufficiency.
Interpretation:
-• CF diagnosis requires: clinical features consistent with CF plus elevated sweat chloride ≥60 mEq/L on two occasions, OR clinical features plus two disease-causing CFTR mutations, OR abnormal newborn screen plus clinical features or family history
-Intermediate sweat chloride values require further evaluation.

Management/Treatment

Acute Management:
-• Pulmonary exacerbations: IV antibiotics based on sputum culture sensitivities (typically 14-day courses), increased airway clearance, nutritional optimization, steroid consideration for severe cases
-Meconium ileus: surgical consultation, contrast enemas may be therapeutic, fluid and electrolyte management
-Distal intestinal obstruction syndrome: oral contrast, prokinetic agents.
Chronic Management:
-• CFTR modulators based on genotype: ivacaftor for gating mutations (G551D, others), lumacaftor/ivacaftor or tezacaftor/ivacaftor for F508del homozygotes, elexacaftor/tezacaftor/ivacaftor for F508del (one or two copies)
-Airway clearance: chest physiotherapy, vest therapy, PEP devices
-Chronic therapies: hypertonic saline, dornase alfa, chronic antibiotics for P
-aeruginosa.
Lifestyle Modifications:
-• High-calorie, high-fat diet with 120-150% normal caloric requirements
-Pancreatic enzyme replacement with all meals and snacks
-Fat-soluble vitamin supplementation (A, D, E, K)
-Salt supplementation especially in hot weather
-Regular exercise as tolerated
-Infection control measures including hand hygiene.
Follow Up:
-• Quarterly visits at accredited CF care centers with multidisciplinary team (pulmonologist, nutritionist, social worker, respiratory therapist, pharmacist)
-Annual assessments: pulmonary function tests, oral glucose tolerance test, bone densitometry, liver function, vitamin levels
-Chronic infection surveillance with quarterly sputum cultures.

Age-Specific Dosing

Medications:
-• CFTR modulators: Ivacaftor 75mg BID (2-5 years), 150mg BID (≥6 years)
-Elexacaftor/tezacaftor/ivacaftor: not approved <12 years, 2 tablets AM + 1 tablet PM (≥12 years)
-Pancreatic enzymes: 1,000-2,500 lipase units/kg/meal, titrated based on symptoms and growth
-Hypertonic saline 3-7%: 4mL BID via nebulizer.
Formulations:
-• Ivacaftor 75mg, 150mg tablets and oral granules for young children
-Elexacaftor/tezacaftor/ivacaftor combination tablets
-Pancreatic enzymes: enteric-coated microspheres or mini-tablets in various strengths
-Dornase alfa 2.5mg/2.5mL nebulizer vials
-Hypertonic saline 3%, 7% nebulizer solutions.
Safety Considerations:
-• CFTR modulator monitoring: transaminase elevations (check ALT/AST before treatment, every 3 months first year), drug interactions with CYP3A inhibitors/inducers, cataracts in children
-Pancreatic enzyme monitoring: fibrosing colonopathy with excessive dosing (>6,000 units lipase/kg/meal)
-Hypertonic saline: bronchospasm risk, pre-bronchodilator recommended.
Monitoring:
-• CFTR modulator therapy: liver function tests every 3 months first year then annually, ophthalmologic exams in children, sweat chloride reduction as biomarker
-Pancreatic function: fecal elastase annually, symptoms of malabsorption
-Growth parameters quarterly, pulmonary function tests quarterly if age-appropriate.

Prevention & Follow-up

Prevention Strategies:
-• Primary prevention through genetic counseling for at-risk families, carrier screening programs, and preimplantation genetic diagnosis
-Secondary prevention focuses on early detection through universal newborn screening to prevent irreversible complications
-Tertiary prevention emphasizes optimal treatment to prevent disease progression and complications.
Vaccination Considerations:
-• Standard childhood immunizations plus additional vaccines: annual influenza, pneumococcal vaccines (PCV13 and PPSV23), COVID-19 vaccination as priority population
-Live vaccines generally safe unless severely immunocompromised from malnutrition
-Household contacts should receive appropriate vaccines including influenza.
Follow Up Schedule:
-• Quarterly routine visits at CF care center with interim visits for acute issues
-Annual comprehensive assessment including complications screening, nutritional assessment, psychosocial evaluation
-Transition planning begins in early adolescence with adult care team introduction
-Emergency protocols for pulmonary exacerbations and complications.
Monitoring Parameters:
-• Growth velocity using CF-specific growth charts and BMI percentiles
-Pulmonary function trends with FEV1 as primary endpoint (when age-appropriate)
-Nutritional status: fat-soluble vitamins, essential fatty acids, inflammatory markers
-Microbiology surveillance: chronic infection detection and antibiotic resistance patterns.

Complications

Acute Complications:
-• Pulmonary exacerbations with increased cough, sputum production, decreased exercise tolerance requiring hospitalization for IV antibiotics
-Pneumothorax in 5-10% of adolescents/adults
-Distal intestinal obstruction syndrome (meconium ileus equivalent)
-Hemoptysis from airway inflammation and infection
-Hypoglycemic episodes from CF-related diabetes.
Chronic Complications:
-• Chronic respiratory failure requiring lung transplantation evaluation
-CF-related diabetes mellitus in 30-50% of adults
-Liver disease with portal hypertension in 5-10%
-Bone disease and fractures from malabsorption and chronic inflammation
-Male infertility (>95%) from congenital bilateral absence of vas deferens.
Warning Signs:
-• Respiratory deterioration: increased cough and sputum, fever, decreased exercise tolerance, weight loss, declining pulmonary function
-Nutritional concerns: poor weight gain, fat-soluble vitamin deficiencies, signs of diabetes
-Gastrointestinal: severe abdominal pain suggesting obstruction, liver-related symptoms.
Emergency Referral:
-• Immediate referral for: massive hemoptysis, pneumothorax, severe respiratory distress, distal intestinal obstruction syndrome not responding to medical therapy
-Urgent referral for: significant pulmonary function decline, treatment-resistant infections, complications requiring subspecialty management including transplant evaluation.

Parent Education Points

Counseling Points:
-• Explain CF as genetic condition requiring lifelong management but with improving outcomes due to better treatments including CFTR modulators
-Discuss genetic counseling for family planning with 25% recurrence risk for future pregnancies
-Emphasize importance of adherence to treatment regimens for optimal outcomes and quality of life.
Home Care:
-• Daily airway clearance techniques appropriate for child's age and preference (vest therapy, manual techniques, exercise)
-Proper administration of pancreatic enzymes with all meals and snacks
-High-calorie nutritional planning and supplementation
-Infection control measures including hand hygiene and avoiding sick contacts.
Medication Administration:
-• Pancreatic enzymes must be taken with all meals and snacks, mixed with acidic foods for infants, not chewed
-CFTR modulators taken with fat-containing foods to enhance absorption
-Nebulized medications in proper sequence (bronchodilator, hypertonic saline, dornase alfa, antibiotics)
-Proper nebulizer maintenance and cleaning.
When To Seek Help:
-• Contact CF team for: increased cough and sputum production, fever, decreased appetite or weight loss, abdominal pain or constipation, signs of dehydration especially in hot weather
-Seek immediate care for: severe breathing difficulty, blood in sputum, severe abdominal pain, signs of pneumothorax (chest pain, sudden breathing difficulty).