Status:
COMPLETED
Therapeutic Zinc in Infant Bacterial Illness
Lead Sponsor:
Centre For International Health
Collaborating Sponsors:
All India Institute of Medical Sciences
Conditions:
Sepsis
Bacterial Infections
Eligibility:
All Genders
1-4 years
Phase:
PHASE2
PHASE3
Brief Summary
Infections are the important cause of high mortality in young infants in developing countries. Zinc is a crucial micronutrient as it influences various immune mechanisms and modulates host resistance ...
Detailed Description
Infant mortality rate continues to be high in most developing countries despite advances in child health care. Infections are the most important cause of deaths in infants. There is increasing recogni...
Eligibility Criteria
Inclusion
- Evidence of possible serious bacterial infection, defined as a CRP \>= 12 mg/L and any one of the following clinical features:
- Fever (axillary temperature \>= 37.5 degrees C) or hypothermia (axillary temperature \<35.5 degrees C).
- Lethargic or unconscious. No attachment to the breast in breast fed infants. No suckling in breast fed infants. Convulsions in the present episode. Bulging fontanel.
- History of acute refusal of feed in the present episode.
- Acute history of excessive cry or irritability in the present episode.
- Fast breathing defined as \>= 60 breaths/minute (on second count) for infants \< 2 months and \>= 50 breaths/min in infants 2 months up to 4 months.
- Grunting in the absence of any non infective cause.
- Cyanosis in the absence of any non infective cause.
- Severe chest in drawing.
- Unexplained shock.
- Diarrhea in present episode.
Exclusion
- Congenital malformations e.g. hydrocephalus, structural CNS malformation.
- Severe birth asphyxia defined as:
- One minute APGAR (if available) of \< 4/10.
- CT scan or MRI or EEG abnormalities if available suggestive of hypoxic ischemic encephalopathy.
- Known structural defects, which interfere with feeding, e.g.cleft palate esophageal abnormalities, intestinal atresia and stenosis, malrotation of the gut,anorectal malformation.
- Subjects requiring ventilation or ionotropic support.
- History of diarrhea in the present episode.
- Known inborn error of metabolism.
- Chronic disorders of other organs e.g. neonatal cholestasis, chronic renal failure, pre-existing seizure disorder.
- Infants born of known HIV mothers.
- Clinical suspicion of necrotising enterocolitis.
- Congenital heart disease.
- Any CVS malformation:
- Congenital heart disease.
- Cyanosis before present episode.
- Presence of murmur \> grade 3/6.
- Ambiguous genitalia.
- Known chromosomal abnormality.
- Infants requiring exchange transfusion.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT00347386
Start Date
July 1 2005
End Date
December 1 2008
Last Update
December 7 2010
Active Locations (3)
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1
Deen Dayal Upadhyay Hospital,
New Delhi, New Delhi, India, 110064
2
All India Institute Of Medical Sciences
New Delhi, New Delhi, India
3
Kalawati Saran Children Hospital
New Delhi, New Delhi, India