Timing of Iron Supplementation in Very Low Birth Weight Infants

Nutritional Status Clinical Trial

Official title:

New Versus Standard Enteral Iron Supplementation Regime in Very Low Birth Weight Infants - A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683527
• Other study ID #: A-34/2006
• Status: Completed
• Phase: N/A
• First received: May 21, 2008
• Last updated: May 21, 2008
• Start date: May 2006
• Est. completion date: January 2007

Study information

• Verified date: May 2008
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 2007
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 60 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Birth Weight
• Nutritional Status

Intervention

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

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences	New Delhi	Delhi (UT)

Sponsors (2)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi	Indian Council of Medical Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum ferritin		60 days postnatal age	No
Secondary	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)	Yes
Secondary	Hematologic and anthropometric parameters		at 60 days of age	No
Secondary	Requirement of blood transfusion		till the end of study period	No