Fast Breathing in Young Infants
Conditions
Keywords
Fast breathing, Young infants, Management, Amoxicillin, Placebo
Brief summary
The aim of the study is to determine optimal management of isolated fast breathing in young infants in a trial design conducted in primary care settings. The investigators hypothesized that proportion of infants who fail therapy will be 4% in each group. A 6% or less difference in failure rate will be considered equivalent.
Detailed description
The management of isolated fast breathing is therefore unknown and our experience suggests that these infants could perhaps be managed without antibiotics. Widespread application of the WHO clinical algorithm could therefore result in the referral of as many as 13.7% (135.7 per 1000 live births) of all infants for isolated fast breathing, the vast majority of these unnecessarily, and exposing infants to a high risk of nosocomial sepsis and hospital mortality in addition to over-burdening health resources.
Interventions
DRUGAmoxicillin
80-100 mg/kg/day in 2 divided doses for 7 days For convenience dose divided into six weight bands Table 2: Dose of amoxicillin Weight band Amount per dose Daily dose Lower Limit (mg or units /kg/d) Upper Limit (mg or units /kg/d) Amoxicillin - desired range 75-100 mg/kg/day (25mg/ml (125mg/5ml); twice daily orally)\* 1.8-1.9 kg 3.0 ml 150 mg 75.4 100.0 2.0-2.4 kg 4.0 ml 200 mg 80.3 100.0 2.5-2.9 kg 5.0 ml 250 mg 83.6 100.0 3.0-3.9 kg 6.0 ml 300 mg 75.2 100.0 4.0-4.9 kg 8.0 ml 400 mg 80.2 100.0 5.0-5.9 kg 10.0 ml 500 mg 83.5 100.0
DRUGSugar Syrup
It will be given 2 times/day for 7 days
Sponsors
Aga Khan University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 59 Days
Healthy volunteers
No
Inclusion criteria
* Young infant (0-59 days of age) * Fast breathing i.e., respiratory rate ≥60 breaths/min * O2 Saturation ≥90% * Resident of catchment area (to ensure complaint and follow up) * Refused hospitalization and investigations * Informed consent is provided by a parent (or legal guardian).
Exclusion criteria
* Preterm infants (born \<37 weeks) * Presence of audible murmur * Any concurrent signs of severe infection: * not feeding well * movement only when stimulated * severe chest in-drawing * axillary temperature ≥38.0oC or ≤35.5oC * Any sign of being critically ill (Cyanosis, bulging fontanel, unable to feed, unable to cry, apnoea, convulsions, unconscious, persistent vomiting) * Weight \<1800gm at the time of presentation * Major congenital malformations or suspected chromosomal abnormalities * Hospitalization for illness in the last two weeks * Previous inclusion in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment failure | Day 8 of enrollemnt | 1. O2 sat \<90% on Day 2 or any time until Day 7. 2. Clinical deterioration: emergence of any sign of being critically ill or severe infection at any time after randomization (as defined in exclusion criteria) 3. Development of serious adverse effect of the study antibiotics (death, organ failure, anaphylactic reaction, severe diarrhoea, disseminated and severe rash). 4. Hospitalization any time after admission in the study. 5. Death anytime within day 1-7 of enrolment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance to treatment | 80% of total dosage | To label as per protocol infant should receive 100% (4 doses) of doses in first 2 days followed by 70% (7 doses) of doses from day 3 to day 8. |
| Proportion of infants relapse | No treatment failure by day 8 and signs of sepsis or fast breathing between day 8-14 | — |
Countries
Pakistan
Outcome results
None listed