Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of Short Course Zinc Therapy (5 vs 10 d) With 20 mg Elemental Zinc Daily in the Treatment of Acute Diarrhoea: A Double-blind Individually Randomized Controlled Community Trial.
Brief Summary: Diarrhoea continues to be a major cause of mortality and morbidity in young children especially in many developing countries. Although the mortality burden of diarrhoea has substantially reduced, the morbidity pattern remained almost unchanged. Recent randomized controlled supplementation trials in developing countries have consistently shown that zinc has the potential to reduce the duration of diarrhoea as well as has preventive effect on childhood diarhroea in subsequent months. Currently, international health agencies recommend zinc as an important adjunct therapy to treat diarrhoea in developing countries where zinc deficiency is highly prevalent and diet is poor in zinc.

The recommendation is to provide 20 mg elemental zinc daily for 10 days during each episode of diarrhoea.

This study aims at evaluating the relative efficacy of two length of 20 mg zinc therapy (5 vs 10 days) during acute diarrhoea in a rural community in a community-based individually randomized placebo-controlled trial with 20 mg zinc daily and will be conducted in seven villages in the ICDDR,B Matlab study area.

The study will require 2050 acute dirrhoeal episodes to be treated who will be randomly allocated to one of the two treatment schedules (20 mg of zinc daily for 5 or 10 days). Children who will be allocated to the shorter duration therapy will receive placebo for the remaining days to complete 10-day treatment. Female Field Workers (FFWs) will conduct diarrhoea surveillance and administer zinc daily at home. Data will be analyzed using appropriate statistical procedure.

Findings of this study will be immensely valuable for deciding recommendation for the duration of zinc therapy in the management of acute diarrhoea in young children and will have profound programmatic and policy implications for scaling up zinc intervention in the community.


Options:
A: Inclusion Criteria:

* Inclusion criteria for clusters: Each cluster will be a rural community characterized by inhabitants with low income and served by one community health center. A primary criterion is that national or other available statistics indicate a prevalence of stunting (mean length for age Z-scores in second year \< -2) of at least 20% in young children.
* Inclusion criteria for individual families:

  * Infant aged 3-4 months;
  * Primarily or exclusively breast feeding with intent to continue breast feeding through at least 1 year.

Exclusion Criteria:

* Exclusion criteria for individual families: Exclusion criteria include any population/family that is receiving or likely to receive free or subsidized complementary foods (or infant formula) through the health system or NGOs; any individual families who are feeding or intend to feed fortified infant formula or micronutrient-fortified commercial complementary foods.
* Exclusion criteria for infants: Infants meeting the following criteria will be excluded from participation:

  1. known congenital anomaly;
  2. infant of multiple births;
  3. known neurological deficit apparent at the time of enrollment (including seizures).
B: Inclusion Criteria:

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 Criteria:

* 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.
C: Inclusion Criteria:

* Infants aged 14 to 28 days born after 37 weeks of gestation and weighing less than or equal to 2.5 kg at birth (\<10th percentile of the National Center for Health Statistics \[NCHS\] median birth weight)
* Either sex
* Resides within 7 km of the hospital

Exclusion Criteria:

* Likely to leave the area of residence within 6 months of enrollment
* Congenital malformations, congenital heart disease, metabolic disorders, renal diseases, etc.
* Non consent for participation
* Illness requiring hospitalization
* Twins
* Preterm
D: Inclusion Criteria:

1. Children less than 5 years with acute watery diarrhoea less than 48 h of duration
2. No medication received other than ORS or home solution
3. Absence of complication or co-morbidities.
4. Absence of severe dehydration

Exclusion Criteria:

1. Age greater than 5 years
2. Diarrhoea more than 48 h duration
3. Unable to eat or drink
4. Already received multiple treatment including zinc
5. Presence of co-morbidities
6. Severe dehydration

Answer: D