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.

Study Overview

• Status: Completed
• Conditions: Nutritional Status
• Intervention / Treatment: Drug: Elemental iron

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi (UT)
    • New Delhi, Delhi (UT), India, 110029
      • All India Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 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 Names: 'Tonoferon' drops, East India Co
No Intervention: 2; No iron supplementation till 60 days of life (Control group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum ferritin	60 days postnatal age

Secondary Outcome Measures

Outcome Measure	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	at 60 days of age
Requirement of blood transfusion	till the end of study period

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences, New Delhi
• Collaborators: Indian Council of Medical Research
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): November 1, 2006
• Study Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: May 21, 2008
• First Submitted That Met QC Criteria: May 21, 2008
• First Posted (Estimate): May 23, 2008

Study Record Updates

• Last Update Posted (Estimate): May 23, 2008
• Last Update Submitted That Met QC Criteria: May 21, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Iron supplementation; Timing; Serum ferritin; Very low birth weight infants
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: A-34/2006