Please select the arm or intervention descriptions that belong 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: Arm Label: Wait and watch (Group D); Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Mometasone spray (Group B); Type: EXPERIMENTAL; Interventions: Drug: Mometasone 50 Mcg/Inh Nasal Spray | Arm Label: antibiotic + histaminic + oxymetazoline drops (Group A); Type: EXPERIMENTAL; Interventions: Drug: Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%) | Arm Label: Oral steroid (Group C); Type: EXPERIMENTAL; Interventions: Drug: Steroid Drug (prednisolone) | Intervention Type: DRUG; Name: Mometasone 50 Mcg/Inh Nasal Spray; Assigned to Arm(s): Mometasone spray (Group B) | Intervention Type: DRUG; Name: Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%); Assigned to Arm(s): antibiotic + histaminic + oxymetazoline drops (Group A) | Intervention Type: DRUG; Name: Steroid Drug (prednisolone); Assigned to Arm(s): Oral steroid (Group C)
B: Intervention Type: PROCEDURE; Name: Insertion of tympanostomy tubes; Assigned to Arm(s): N/A
C: Arm Label: Montelukast; Type: EXPERIMENTAL; Interventions: Drug: Monteleukast | Arm Label: Mometasone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Mometasone | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Monteleukast; Assigned to Arm(s): Montelukast | Intervention Type: DRUG; Name: Mometasone; Assigned to Arm(s): Mometasone
D: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Amoxycillin | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo equivalent to amoxycillin | Intervention Type: DRUG; Name: Amoxycillin; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo equivalent to amoxycillin; Assigned to Arm(s): 2

Answer: D