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| Name | Class |
|---|---|
| Indian Council of Medical Research | OTHER_GOV |
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To examine if early iron supplementation (starting oral iron at 14 days of life) would improve the nutritional iron status(measured by serum ferritin) of very low birth weight infants at postnatal age of 60 days, when compared to the standard regime of starting iron at 2 months of life.
Smaller the preterm infants at birth, more susceptible they are to iron deficiency due to low body iron stores. Despite having low iron stores, very low birth weight (VLBW) infants are not usually started on iron supplementation till they reach a postnatal age of 6 to 8 weeks. Such delayed supplementation can lead to rapid depletion of iron stores when erythropoiesis becomes active (by 8 weeks of life).
Depletion of iron stores is the first step in the continuum of changes that occur in iron deficiency. Iron deficiency induces biochemical defects (such as impaired synthesis of DNA and collagen) even before any features of microcytic, hypochromic anemia become evident. The rapidly maturing preterm brain is especially vulnerable to the effects of iron deficiency; poor school-age performance has been reported among children who had low iron stores in their neonatal period.
Early iron supplementation i.e. starting iron once the infant reaches full enteral feeds could potentially improve the iron stores and prevent its depletion. Surprisingly, few studies are available till date to support (or refute!) this view. The current study was designed to test the hypothesis whether early iron supplementation would increase the nutritional iron status (as measured by serum ferritin) at 60 days of life when compared to the existing regime of starting iron at the age 2 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Starting oral iron at day 14 of life (Early Iron group) |
|
| 2 | No Intervention | No iron supplementation till 60 days of life (Control group) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elemental iron | Drug | Iron in the dose of 3-4 mg/kg/day (of elemental iron) PO once daily mixed with expressed breast milk from 14 days of life till the end of study period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum ferritin | 60 days postnatal age |
| Measure | Description | Time Frame |
|---|---|---|
| Composite outcome of neonatal morbidities that include chronic lung disease [CLD], necrotizing enterocolitis [NEC-any stage], periventricular leucomalacia [PVL], and retinopathy of prematurity [ROP] requiring treatment | Till the end of study period (2 months) | |
| Hematologic and anthropometric parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M Jeeva Sankar, MD DM | All India Institute of Medical Sciences | Principal Investigator |
| Vinod K Paul, MD PhD | All India Institute of Medical Sciences | Study Chair |
| Ramesh Agarwal, MD DM | All India Institute of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All India Institute of Medical Sciences | New Delhi | Delhi (UT) | 110029 | India |
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| at 60 days of age |
| Requirement of blood transfusion | till the end of study period |