Please select the eligibility criteria that correspond to the clinical trial below.
Title: Impact of Zinc Supplementation in Low Birth Weight Infants on Severe Morbidity, Mortality and Zinc Status: A Randomized Controlled Trial
Brief Summary: There are currently no interventions available to substantially reduce the incidence of low birth weight (LBW) apart from increasing the age at marriage, maternal iron supplementation and possibly improved energy intakes.

The current view of the medical and public health community in India is that the immediate focus should be on promoting survival and development of low birth weight infants who have nearly a 6 to 7 fold higher mortality during infancy than those with normal birth weight.

Low serum zinc is associated with increased incidence of diarrhea and pneumonia. There is sufficient evidence in under-threes that during acute illness, zinc supplementation (1-2 recommended dietary allowance \[RDA\]) reduces incidence of all episodes of diarrhea, severe diarrhea and pneumonia. A number of initial published trials also show significant effect of zinc treatment on pneumonia. With the large and consistent effects of zinc supplementation on the incidence and severity of infections, an effect on child mortality is likely.

Available literature suggests the distinct possibility of reduced neonatal and infant mortality in LBWs receiving 1 RDA of zinc daily. A pilot study in India showed a 54% reduction in mortality in LBW infants. These findings were based on a very small sample and therefore considered insufficient to change policy.

A positive impact in the proposed study will provide an important tool for reduction of infant mortality which is currently stagnant and government acceptance for such a program is likely to be very high. We, the researchers at the Society for Applied Studies, believe this study has the potential for decreasing infant mortality from its current level.


Options:
A: 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
B: 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
C: Inclusion Criteria:

* All available children who received iron and zinc study during infancy

Exclusion Criteria:

* Neurological disorder
D: 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.

Answer: A