Please select the eligibility criteria that correspond to the clinical trial below.
Title: Amoxycillin Versus Placebo for Resolution of Otitis Media With Effusion and Prevention of Acute Otitis Media With Perforation in Aboriginal Infants: a Randomised Controlled Trial.
Brief Summary: This clinical trial was conducted in a population where tympanic membrane perforation occurs in 60% infants in the first year of life. Nasopharyngeal colonisation (nasal contamination) with pathogenic bacteria occurs within weeks of life and predicts persistent middle ear infection throughout childhood. The trial aimed to assess whether twice daily antibiotics commencing at first detection of middle ear effusion would cure the infection and/or prevent disease progression, compared to placebo.

The study was conducted in three remote Aboriginal communities in the Northern Territory of Australia. The annual birth cohort was 45.

Aboriginal infants were seen as soon as possible after birth, and at 2 weekly intervals until middle ear effusion was detected by pneumatic otoscopy and tympanometry. Following consent, infants were randomised to either amoxycillin(50 mg/kg/d BD) or placebo equivalent for up to 24 weeks, or until normal middle ear status was detected at 2 consecutive monthly scheduled examinations. At monthly examinations the infant also had a general health check, parents were interviewed, child's medical record was reviewed, and nasopharyngeal swabs were collected.


Options:
A: Inclusion Criteria:

* Australian Aboriginal
* Living in participating remote community
* Less than 12 months of age

Exclusion Criteria:

* Less than 32 weeks gestation
* Chronic condition requiring continuous antibiotic
* Ear, nose or throat abnormality
B: 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
C: 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.
D: Inclusion Criteria:

* history of mild ear ache or decreased hearing for three or more months, plus
* intact and immobile tympanic membrane by pneumatic otoscopy
* Type B tympanogram

Exclusion Criteria:

* any external ear condition that hampers visualization of tympanic membrane
* lost to follow up

Answer: A