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Timing of Iron Supplementation in Very Low Birth Weight Infants

This study has been completed.
Sponsor:
Collaborator:
Indian Council of Medical Research
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00683527
First received: May 21, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Nutritional Status
 Drug: Elemental iron

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: New Versus Standard Enteral Iron Supplementation Regime in Very Low Birth Weight Infants - A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight Iron
U.S. FDA Resources

Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Serum ferritin [ Time Frame: 60 days postnatal age ] [ Designated as safety issue: No ]

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 [ Time Frame: Till the end of study period (2 months) ] [ Designated as safety issue: Yes ]
  • Hematologic and anthropometric parameters [ Time Frame: at 60 days of age ] [ Designated as safety issue: No ]
  • Requirement of blood transfusion [ Time Frame: till the end of study period ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: May 2006
Study Completion Date: January 2007
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 'Tonoferon' drops, East India Co
No Intervention: 2
No iron supplementation till 60 days of life (Control group)

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

Ages Eligible for Study:   up to 60 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683527

Locations
India
All India Institute of Medical Sciences
New Delhi, Delhi (UT), India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
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
  More Information

No publications provided

Responsible Party: M Jeeva Sankar, Department of Pediatrics, AIIMS, New Delhi
ClinicalTrials.gov Identifier: NCT00683527     History of Changes
Other Study ID Numbers: A-34/2006
Study First Received: May 21, 2008
Last Updated: May 21, 2008
Health Authority: India: Institutional Review Board

Keywords provided by All India Institute of Medical Sciences, New Delhi:
Iron supplementation
Timing
Serum ferritin
Very low birth weight infants

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms
Iron
Trace Elements
 Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013