Timing of Iron Supplementation in Very Low Birth Weight Infants

Not Applicable

Completed

• Conditions: Nutritional Status
• Interventions: Drug: Elemental iron

• Registration Number: NCT00683527
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

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.

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2006-11
• Study Completion: 2007-01
• Status Verified: 2008-05
• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-21
• Last Update Submitted: 2008-05-21
• Study First Posted: 2008-05-23
• Last Update Posted: 2008-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

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

Read More

Exclusion Criteria

• Major congenital anomalies
• Rh hemolytic disease
• Twin-to-twin transfusion syndrome
• Refusal to give consent

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Elemental iron	Starting oral iron at day 14 of life (Early Iron group)

Primary Outcome Measures

Name	Time	Method
Serum ferritin	60 days postnatal age

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 New Delhi, Delhi (UT), India