Please select the eligibility criteria that correspond to the clinical trial below.
Title: Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
Brief Summary: Otitis media is one of the most common infections among children and is a complication in about 30% of common colds. The most common complication of acute otitis media is otitis media with effusion. Some studies have reported the effects of montelukast and mometasone nasal spray in treatment of otitis media with effusion. However, current information is inadequate in this issue. The aim of this study was to compare the effectiveness of montelukast and mometasone nasal spray in treatment of otitis media with effusion in children attending Koodakan hospital in Bandar Abbas, Iran.


Options:
A: Inclusion Criteria:

* Male or female, age 0-18 years
* Patients with serous otitis media and/or negative middle ear pressure as documented by otoscopic examination and tympanometry will be considered for enrollment
* Pregnant

Exclusion Criteria:

* Unwilling to discontinue breast feeding, when applicable
* Active upper respiratory infection
* Nasopharyngeal mass
* Chronic infectious otitis media
* Cholesteatoma
* Acute infectious otitis media
* History of otologic surgery other than placement of a pressure equalizer tube in the affected ear
* History of radiation therapy to the head and neck region
* Neuromuscular disease
* Cystic fibrosis
* Immunodeficiency
* Mucociliary disorders
* Craniofacial disorders/syndromes
* Cleft palate
* Development delay and/or symptoms suggestive of perilymph fistula
B: Inclusion criteria:

* Children aged 9-36 months.
* Children with at least one Greenlandic born parent with at least one Greenlandic born parent
* American Society of Anaesthesiologists physical status classification class 1 and 2
* B- or C2 - type curve measured by tympanometry at two visits three-four months apart or three episodes of acute otitis media in six months according to medical records or four episodes of acute otitis media in 12 months according to medical records
* Signed informed consent, signed by the legal guardian Exclusion criteria
* Children with orofacial cleft, Downs syndrome or known generalised immune deficiency
* American Society of Anaesthesiologists physical status classification class \> 2.
* Lack of signed informed consent, signed by the legal guardian.

Description of experimental and control intervention Experimental intervention: The intervention group will be treated with bilateral Donaldson ventilation tubes administered in general anaesthesia Control intervention: The control intervention is based on the current practice in Greenland, which includes systemic antibiotic treatment as well as aural toilette and topical antibiotics. Ventilation tube insertion during the study period is not accepted in the control group.

Children in the intervention group as well as the control group will be seen once a year by the visiting ear-nose-and throat (ENT)-specialist and have a final consultation after at least two years after randomisation.
C: Inclusion Criteria:

* Healthy, less than 62 days of age at enrollment

Exclusion Criteria:

* birth weight less than 5 lb (2268 g)
* small for gestational age
* history of neonatal asphyxia or other serious illness
* major congenital abnormality or chronic illness
* multiple birth
* sibling enrolled in the study
* in foster care or adopted before enrollment
* mother dead, seriously ill, a known drug or alcohol abuser before enrollment
* mother judged by study personnel to be too limited socially or intellectually to give informed consent or adhere to the study protocol
* mother less than 18 years of age
* English not the only household language
D: Inclusion Criteria:

* • Children who were between 2 to 6 years old

  * Definite diagnosis of OME with symptoms and examination

Exclusion Criteria:

* • Currently were using corticosteroids or prophylactic monteleukast

  * Chronic pulmonary or cardiac diseases or immune deficiency
  * Allergic rhinitis
  * Hypersensitivity to monteleukast or corticosteroids
  * Avoidance of parents to fill the written informed consent

Answer: D