Prevalence of iron deficiency in 3.5 month infants in a tertiary care teaching hospital: A Cross sectional study

STUDY TITLE: Prevalence of iron deficiency in 3.5 month infants in a tertiary care

teaching hospital: A Cross Sectional Study

RATIONALE: Prevalence of iron deficiency has been increasing despite iron supplementation

programs. Iron deficiency has been associated with adverse effects on neuro-development, low

IQ and anemia. Therefore, there is an urgent need for assessing the iron status in young infants

and re-considering the age for initiating iron supplementation.

AIM: To estimate the prevalence of iron deficiency in infants at 3.5 months of age.

OBJECTIVES: Primary: To estimate the proportion of infants at age 3.5 having iron

deficiency (Serum Ferritin <12 micrograms/L) in an immunization clinic; Secondary : To

estimate the proportion of infants at age 3.5 months having iron deficiency anemia (Hb<10.5

g/dL and serum ferritin <12 micrograms/L) in an immunisation clinic.

STUDY SETTING: Immunisation clinic, Department of Paediatrics and Department of

Pathology, UCMS & GTB Hospital, Delhi.

STUDY DESIGN: Cross Sectional Study .

TIME FRAME: April 2024-August 2025

ETHICS: Study will be conducted after approval from Institutional Ethics Committee for

Human Research. Informed written consent will be obtained from parents or guardians.

SAMPLE SIZE: Considering the prevalence of iron deficiency anemia at 3.5 months as

21.4% with margin of error 5%, with 95% confidence interval, at α=5%, a sample size of 258

infants of 3.5 months age is required.

PARTICIPANTS: Inclusion criteria: born at term (37 to 42 weeks gestation), aged 3.5-4

months; Exclusion Criteria: history of any acute illness requiring hospitalization for more

than a week, any chronic systemic illness, any history of blood transfusion, history of iron

supplementation.

METHODOLOGY: All term infants of age 3.5 months attending immunization clinic will

be recruited after written informed consent from parents or guardians. Venous blood samples

will be taken and CBC and serum ferritin will be measured. Participants will be considered to

have Iron deficiency if serum ferritin <12 micrograms/L and Iron deficiency anemia if

hemoglobin <10.5 g/dl and serum ferritin <12 mcg/L.

OUTCOMES: Primary: Proportion of infants having Serum Ferritin <12 micrograms/L at

3.5 months of age; Secondary: Proportion of infants having Hemoglobin (Hb) <10.5 g/dL

and serum ferritin <12 micrograms/L at 3.5 months of age.

STATISTICAL ANALYSIS: Data will be entered in MS Excel sheet and outcome measures

will be reported as proportions.