Antibiotics might have more effect in the children less than 2 years of age.
ID
Bron
Verkorte titel
Aandoening
acute otitis media in general practice, antibiotics, placebo, infants
acute middenoorontsteking in huisartsenpraktijk, antibiotica en placebo, kinderen onder de 2 jaar.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Persistent symptoms at day 4, assessed by the doctor and defined as persistent earache, fever, crying or being irritable
Achtergrond van het onderzoek
This trial was planned to see what the effectiveness was of antibiotic treatment in childeren under 2 years of age with acute otitis media in general practice. 7-8 children in this age-group needed to be treated with antibiotics to improve symptomatic outcome at day 4 in one child.
Doel van het onderzoek
Antibiotics might have more effect in the children less than 2 years of age.
Onderzoeksopzet
Evaluation at 4 days, 11 days, 6 weeks, 3 months and 6 months.
Further first 10 days a diary.
Onderzoeksproduct en/of interventie
Amoxicillin suspension 40mg/kg/day in three divide doses for 10 days or placebo suspension.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Children aged 6 months to two years with acute otitis media in general practice
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Antibiotic treatment in de preceding 4 weeks
2. Allergy to amoxicillin
3. Compromised immunity
4. Craniofacial abnormalities
5. Down's syndrome
6. Being entered in this study before.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1365 |
| NTR-old | NTR1426 |
| Ander register | : METC, UMC Utrecht: I93-63 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
Samenvatting resultaten
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- Damoiseaux RAMJ, van Balen FAM, Hoes AW, Verheij TJM, Melker RA. Primary care based randomised, double blind trial of amoxicillin versus placebo for acute otitis media in children aged under 2 years. BMJ 2000;320:350-4.
<br><br>
- Damoiseaux RAMJ, Sanders LAM, van Balen FAM, Rijkers GT. Sibling history of recurrent acute otitis media correlates with low IgG2 anti-pneumococcal polysaccharide antibody levels. Pediatr Infect Dis J 2000;19:176-7.
<br><br>
- Damoiseaux RAMJ, van Balen FAM. Duration of clinical symptoms in children under two years of age with acute otitis media. Eur J Gen Pract 2000;6:48-51.
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- Damoiseaux RAMJ, Rovers MM, van Balen FAM, Hoes AW, de Melker RA. Long-term prognosis of acute otitis media in infancy: determinants fo recurrent acute otitis media and persistent middle ear effusion. Fam Pract 2006;23:40-5.