What is the preferred treatment for respiratory issues such as congestion or allergies in an infant less than 6 months old, Salinase (saline nasal spray) or an antihistamine (e.g. diphenhydramine)?

Saline Nasal Irrigation is the Only Safe Option for Infants Under 6 Months

For infants less than 6 months old with nasal congestion, saline nasal drops or irrigation (Salinase) is the recommended treatment, while antihistamines are contraindicated due to documented fatalities and serious adverse events in this age group. 1, 2

Why Antihistamines Are Dangerous in This Age Group

The evidence against antihistamine use in infants under 6 months is compelling and unequivocal:

• Between 1969-2006, there were 69 fatalities associated with antihistamines (diphenhydramine, brompheniramine, chlorpheniramine) in children age 6 years and younger, with 41 deaths occurring in children under 2 years of age. 1

• The FDA's Nonprescription Drugs and Pediatric Advisory Committees recommended in 2007 that OTC cough and cold medications, including antihistamines, should not be used in children below 6 years of age due to lack of established efficacy and significant safety concerns. 1

• Antihistamines in infants have been associated with agitated psychosis, ataxia, hallucinations, and death, even at recommended doses. 2

• The American Academy of Pediatrics and FDA specifically recommend against using first-generation antihistamines (like diphenhydramine) in children under 6 years. 3, 2

Why Saline is the Appropriate Choice

Saline nasal irrigation provides a safe and effective alternative:

• Saline drops or irrigation are specifically recommended by the American Academy of Pediatrics as first-line treatment for nasal congestion in infants under 6 months. 2

• Isotonic and hypertonic saline solutions provide modest benefit for reducing nasal congestion symptoms with minimal side effects, low cost, and generally good patient acceptance. 3, 2

• Saline nasal lavage is safe and effective for treatment of nasal congestion in babies with viral upper respiratory tract infections, which are the most common cause of nasal obstruction in this age group. 4, 5

• Neonates are obligate nasal breathers until at least 2 months old, making nasal obstruction particularly problematic and requiring safe interventions like saline irrigation. 4

Clinical Algorithm for Infants Under 6 Months

Step 1: Use saline nasal drops (2-3 drops per nostril) or gentle saline irrigation to loosen secretions. 2, 4

Step 2: Follow with gentle nasal aspiration using a bulb syringe or nasal aspirator device to remove loosened mucus. 4, 5

Step 3: Repeat as needed throughout the day, particularly before feeding and sleep. 4

Step 4: Avoid all antihistamines, decongestants, and OTC cough/cold medications in this age group. 1, 2

Important Safety Considerations

Common pitfall to avoid: Do not use topical vasoconstrictors (decongestants) in infants below age 1 year, as there is a narrow margin between therapeutic and toxic doses, increasing the risk for cardiovascular and CNS side effects. 1

The evidence is clear and consistent across multiple guideline organizations: saline irrigation is the only appropriate treatment for nasal congestion in infants under 6 months, while antihistamines pose unacceptable safety risks with documented fatalities. 1, 3, 2