Clinical trial NCT00683527: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Status
Keywords: Iron supplementation
Timing
Serum ferritin
Very low birth weight infants
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Indian Council of Medical Research
First posted: 2008-05-23
Enrollment: 46
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Serum ferritin
timeFrame: 60 days postnatal age
Secondary outcomes:
measure: 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
timeFrame: Till the end of study period (2 months)
measure: Hematologic and anthropometric parameters
timeFrame: at 60 days of age
measure: Requirement of blood transfusion
timeFrame: till the end of study period
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi (UT)
Study officials:
affiliation: All India Institute of Medical Sciences
name: M Jeeva Sankar, MD DM
role: PRINCIPAL_INVESTIGATOR
affiliation: All India Institute of Medical Sciences
name: Vinod K Paul, MD PhD
role: STUDY_CHAIR
affiliation: All India Institute of Medical Sciences
name: Ramesh Agarwal, MD DM
role: STUDY_CHAIR
References: