Which children require Respiratory Syncytial Virus (RSV) prophylaxis?

RSV Prophylaxis Indications in Children

Palivizumab prophylaxis should be administered to infants born before 29 weeks, 0 days' gestation who are younger than 12 months at the start of RSV season, infants with chronic lung disease requiring medical support, and select children with hemodynamically significant congenital heart disease. 1, 2

Primary Indications for Prophylaxis

Preterm Infants Without CLD or CHD

• Infants born <29 weeks, 0 days' gestation and <12 months old at RSV season start qualify for prophylaxis 1, 3, 4
• Infants born ≥29 weeks, 0 days' gestation do NOT universally qualify based on prematurity alone and require additional qualifying conditions (CLD, CHD, or other specific criteria) 1, 4
• For infants born during RSV season, fewer than 5 monthly doses will be needed 1

Chronic Lung Disease (CLD) of Prematurity

• First year of life: Infants <12 months with CLD who required medical therapy (supplemental oxygen, chronic corticosteroids, or diuretics) are eligible 1, 3
• Second year of life: Only infants who continue to require medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) during the 6-month period BEFORE the start of the second RSV season qualify 1, 4
• If medical support is discontinued in the second year, prophylaxis should NOT be given 1, 3

Hemodynamically Significant Congenital Heart Disease (CHD)

Children ≤12 months old with the following cardiac conditions qualify 1, 4:

• Acyanotic heart disease receiving medication for congestive heart failure AND requiring cardiac surgical procedures 1, 4
• Moderate to severe pulmonary hypertension 1, 4
• Cyanotic heart defects (decisions should be made in consultation with pediatric cardiologist) 1, 4

Do NOT give prophylaxis for hemodynamically insignificant heart disease (e.g., secundum atrial septal defect) 1, 4

Special Populations Where Prophylaxis MAY Be Considered

Immunocompromised Children

• Profoundly immunocompromised children <24 months during RSV season may be considered for prophylaxis 1, 3, 4
• Children <2 years undergoing cardiac transplantation during RSV season may receive prophylaxis 1, 3, 4
• No population-based efficacy data exist for this group 1

Neuromuscular Disease and Airway Abnormalities

• Children with pulmonary abnormality or neuromuscular disease impairing ability to clear upper airway secretions qualify 2
• Infants with congenital abnormalities of the airway or neuromuscular conditions compromising handling of respiratory secretions qualify 2

Cystic Fibrosis

• Routine prophylaxis is NOT recommended for cystic fibrosis, including newborns diagnosed by screening 1, 3
• May be considered ONLY if clinical evidence of CLD AND/OR nutritional compromise exists in the first year of life 1, 3, 4

Down Syndrome

• Routine prophylaxis is NOT recommended unless qualifying conditions are present: prematurity <29 weeks, CHD, CLD, or airway clearance issues 1, 4
• Limited data show only slight increase in RSV hospitalization rates, insufficient to justify routine use 1

Dosing and Administration

Standard Protocol

• 15 mg/kg intramuscularly every 30 days throughout RSV season 2, 3, 4, 5
• Maximum 5 monthly doses for most eligible infants 2, 3, 5
• Initiate in November and continue through March in most areas 3
• First dose should be given 48-72 hours before NICU discharge or promptly after discharge for qualifying infants 1, 2

Post-Surgical Dosing

Critical: An additional 15 mg/kg dose must be administered after cardiac bypass or ECMO because these procedures decrease palivizumab serum concentration by 58% 1, 2, 4

When to STOP Prophylaxis

Breakthrough RSV Hospitalization

Discontinue monthly prophylaxis immediately if breakthrough RSV hospitalization occurs due to extremely low likelihood (<0.5%) of second RSV hospitalization in the same season 1, 2

What Prophylaxis Does NOT Do

Contraindicated Uses

• NOT effective for treatment of established RSV disease - palivizumab is prophylaxis only, not therapeutic 1, 3, 5
• NOT recommended for preventing recurrent wheezing or asthma 3
• NOT recommended for controlling nosocomial RSV outbreaks in NICU or hospital settings 1, 3
• Strict infection control practices remain the basis for reducing healthcare-associated RSV disease 1

Clinical Impact and Limitations

The benefit of palivizumab is limited in scope 1:

• Results in 45-55% reduction in RSV hospitalization rates 5, 6
• No measurable effect on mortality 1
• Minimal effect on subsequent wheezing 1
• Limited effect on RSV hospitalizations at population level 1

Common Pitfalls to Avoid

• Failure to give post-bypass dose: Results in suboptimal protection due to 58% decrease in drug levels 2, 4
• Continuing prophylaxis in second year without ongoing medical support: Only justified if child still requires oxygen, diuretics, or corticosteroids 1, 3
• Using for infants ≥29 weeks without qualifying conditions: Prematurity alone at this gestational age does not justify prophylaxis 1, 4
• Attempting to use therapeutically: Palivizumab has no role in treating active RSV infection 1, 3, 5