Timing of Iron Supplementation in Very Low Birth Weight Infants
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||New Versus Standard Enteral Iron Supplementation Regime in Very Low Birth Weight Infants - A Randomized Controlled Trial|
- Serum ferritin [ Time Frame: 60 days postnatal age ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Till the end of study period (2 months) ] [ Designated as safety issue: Yes ]
- Hematologic and anthropometric parameters [ Time Frame: at 60 days of age ] [ Designated as safety issue: No ]
- Requirement of blood transfusion [ Time Frame: till the end of study period ] [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Study Completion Date:||January 2007|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
Starting oral iron at day 14 of life (Early Iron group)
Drug: Elemental iron
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
Other Name: 'Tonoferon' drops, East India Co
No Intervention: 2
No iron supplementation till 60 days of life (Control group)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683527
|All India Institute of Medical Sciences|
|New Delhi, Delhi (UT), India, 110029|
|Principal Investigator:||M Jeeva Sankar, MD DM||All India Institute of Medical Sciences, New Delhi|
|Study Chair:||Vinod K Paul, MD PhD||All India Institute of Medical Sciences, New Delhi|
|Study Chair:||Ramesh Agarwal, MD DM||All India Institute of Medical Sciences, New Delhi|