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Timing of Iron Supplementation in Very Low Birth Weight Infants

Primary Purpose

Nutritional Status

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Elemental iron
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nutritional Status focused on measuring Iron supplementation, Timing, Serum ferritin, Very low birth weight infants

Eligibility Criteria

14 Days - 60 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • All India Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Starting oral iron at day 14 of life (Early Iron group)

No iron supplementation till 60 days of life (Control group)

Outcomes

Primary Outcome Measures

Serum ferritin

Secondary Outcome Measures

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
Hematologic and anthropometric parameters
Requirement of blood transfusion

Full Information

First Posted
May 21, 2008
Last Updated
May 21, 2008
Sponsor
All India Institute of Medical Sciences, New Delhi
Collaborators
Indian Council of Medical Research
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1. Study Identification

Unique Protocol Identification Number
NCT00683527
Brief Title
Timing of Iron Supplementation in Very Low Birth Weight Infants
Official Title
New Versus Standard Enteral Iron Supplementation Regime in Very Low Birth Weight Infants - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
All India Institute of Medical Sciences, New Delhi
Collaborators
Indian Council of Medical Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional Status
Keywords
Iron supplementation, Timing, Serum ferritin, Very low birth weight infants

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Starting oral iron at day 14 of life (Early Iron group)
Arm Title
2
Arm Type
No Intervention
Arm Description
No iron supplementation till 60 days of life (Control group)
Intervention Type
Drug
Intervention Name(s)
Elemental iron
Other Intervention Name(s)
'Tonoferon' drops, East India Co
Intervention Description
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
Primary Outcome Measure Information:
Title
Serum ferritin
Time Frame
60 days postnatal age
Secondary Outcome Measure Information:
Title
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)
Title
Hematologic and anthropometric parameters
Time Frame
at 60 days of age
Title
Requirement of blood transfusion
Time Frame
till the end of study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Days
Maximum Age & Unit of Time
60 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M Jeeva Sankar, MD DM
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vinod K Paul, MD PhD
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ramesh Agarwal, MD DM
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Study Chair
Facility Information:
Facility Name
All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi (UT)
ZIP/Postal Code
110029
Country
India

12. IPD Sharing Statement

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Timing of Iron Supplementation in Very Low Birth Weight Infants

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