Community Based Management of Fast Breathing in Infants Aged < 60 Days in Low-income Settlements of Karachi

Fast Breathing in Young Infants Clinical Trial

— MAT-YI  

Official title:

Community Based Management of Fast Breathing in Infants Aged < 60 Days: A Double-Blind, Randomized Placebo-Controlled Trial in Low-income Settlements of Karachi

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01533818
• Other study ID #: 1979-CHS-ERC-11
• Status: Terminated
• Phase: Phase 4
• First received: February 13, 2012
• Last updated: June 2, 2014
• Start date: May 2012
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Aga Khan University
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 963
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 59 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fast Breathing in Young Infants
• Respiratory Aspiration

Intervention

Drug:
• Amoxicillin
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
• Sugar Syrup
It will be given 2 times/day for 7 days

Locations

Country	Name	City	State
Pakistan	Primary Health Centers	Karachi	Sind

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment failure	O2 sat <90% on Day 2 or any time until Day 7.; Clinical deterioration: emergence of any sign of being critically ill or severe infection at any time after randomization (as defined in exclusion criteria); Development of serious adverse effect of the study antibiotics (death, organ failure, anaphylactic reaction, severe diarrhoea, disseminated and severe rash).; Hospitalization any time after admission in the study.; Death anytime within day 1-7 of enrolment	Day 8 of enrollemnt	Yes
Secondary	Compliance to treatment	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.	80% of total dosage	Yes
Secondary	Proportion of infants relapse		No treatment failure by day 8 and signs of sepsis or fast breathing between day 8-14	Yes

External Links

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