Timing of Iron Supplementation in Very Low Birth Weight Infants

This study has been completed.
Sponsor:
Collaborator:
Indian Council of Medical Research
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00683527
First received: May 21, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted

May 21, 2008
May 21, 2008
May 2006
November 2006   (final data collection date for primary outcome measure)
Serum ferritin [ Time Frame: 60 days postnatal age ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Timing of Iron Supplementation in Very Low Birth Weight Infants
New Versus Standard Enteral Iron Supplementation Regime in Very Low Birth Weight Infants - A Randomized Controlled Trial

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Nutritional Status
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
  • Experimental: 1
    Starting oral iron at day 14 of life (Early Iron group)
    Intervention: Drug: Elemental iron
  • No Intervention: 2
    No iron supplementation till 60 days of life (Control group)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
January 2007
November 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Infants who have reached at least 100 ml/kg/day of oral feeds by day 14 of life

Exclusion Criteria:

  • Major congenital anomalies
  • Rh hemolytic disease
  • Twin-to-twin transfusion syndrome
  • Refusal to give consent
Both
up to 60 Days
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00683527
A-34/2006
No
M Jeeva Sankar, Department of Pediatrics, AIIMS, New Delhi
All India Institute of Medical Sciences, New Delhi
Indian Council of Medical Research
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
All India Institute of Medical Sciences, New Delhi
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP