Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Palivizumab Treatment on Subsequent Recurrent Wheezing in Preterm Infants: Case-control Study by Scientific Committee of Recurrent Wheezing (SCREW)
Brief Summary: The hypothesis of the present study is that the prophylaxis with palivizumab to prevent the severe RS virus infection during the infancy among preterm infants may reduce the risk of subsequent recurrent wheezing in childhood.

The infants born between July 1st and December 31st in 2007 with the gestational age between 33 and 35 weeks were enrolled into the study at the end of RS virus infection season, April 2008. The infants were unintentionally divided into two groups, either palivizumab treated or untreated group at the enrollment, because the timing for palivizumab prophylaxis were already ended.

The study infants will be followed up until the age of 3 with recording the incidence of either parent reported or physician diagnosed recurrent wheezing.

The difference of the incidence of the recurrent wheezing between the groups will be analyzed with Kaplan-Meier method.


Options:
A: Inclusion Criteria:

* Infants born July \~ December 2007 at 33\~35 weeks of gestation
* Infants administered at least 3 doses of palivizumab during the first 6 months of life (Palivizumab treated)
* Infants not administered any doses of palivizumab during the first 6 months of life (Palivizumab untreated)

Exclusion Criteria:

* Intrauterine growth retardation (less than -2.5SD)
* Infants with chronic lung disease (CLD) or other respiratory disease
* Infants received mechanical ventilation
* Infants with chronic heart disease (CHD) or congenital anomaly (such as immunodeficiency)
B: Inclusion Criteria:

* Infants ≤ 3 months-old, presenting to the main pediatric ER with acute bronchiolitis associated with positive RSV rapid antigen test.

Exclusion Criteria:

* Patients will be excluded from the study if they had 1 or more of the following characteristics:

  * Received monoclonal antibody or IVIG within the last 3 months prior to randomization.
  * Receipt of steroids within 2 days before randomization.
  * Hypersensitivity to monoclonal antibodies or immunoglobulin products.
  * Immunodeficiency.
  * Suspected sepsis.
  * Seizure disorders.
  * Neuromuscular disorders.
  * Congenital heart disease.
  * Major congenital anomalies of respiratory tract.
C: Inclusion Criteria:

* The child must have been born at less than or equal to 35 weeks gestation and be less than or equal to 6 months of age at the time of entry into the study (child must be entered on or before his/her 6-month birthday); or the child must be less than or equal to 24 months of age at the time of entry into the study (child must be entered on or before his/her 24-month birthday) and diagnosed with chronic lung disease (CLD) of prematurity with stable or decreasing doses of diuretics, steroids, or bronchodilators, or treatment with supplemental oxygen, within the previous 6 months.
* The child must be in general good health at the time of study entry.
* The child's parent(s)/legal guardian must provide written informed consent.
* The child must be able to complete the follow-up visits through 120-150 days from last injection of study drug.
* Parent(s)/legal guardian of patient must have available telephone access.

Exclusion Criteria:

* Hospitalized at the time of study entry (unless discharge is expected within 10 days after entry into the study)
* Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure \[CPAP\])
* Congenital heart disease (CHD) (children with medically or surgically corrected \[closed\] patent ductus arteriosus and no other CHD may be enrolled)
* Evidence of infection with hepatitis A, B, or C virus
* Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection (a child of a mother with known HIV infection must be proven to be uninfected at the time of enrollment)
* Suspected serious allergic or immune-mediated events with prior receipt of palivizumab
* Acute illness or progressive clinical disorder
* Active infection, including acute RSV infection, at the time of enrollment
* Previous reaction to intravenous immunoglobulin (IGIV), blood products, or other foreign proteins
* Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV \[RespiGam\], IVIG, or palivizumab) or any investigational agents
* Previous participation in a clinical trial of motavizumab
* Currently participating in any investigational study
D: Inclusion Criteria:

* Infants born July \~ December 2007 at 33\~35 weeks of gestation

Exclusion Criteria:

* Intrauterine growth retardation (less than -2.5SD)
* Infants with chronic lung disease (CLD) or other respiratory disease
* Infants received mechanical ventilation.
* Infants with chronic heart disease (CHD) or congenital anomaly (such as immunodeficiency).
* Infants received less than 3 doses of palivizumab during the first 6 months of life

Answer: D