Burden of latent iron deficiency in healthy new-born babies.

Not yet recruiting

Conditions: Newborn affected by other maternalcomplications of pregnancy,

Registration Number: CTRI/2022/11/047101

Lead Sponsor: Command Hospital Airforce Bangalore

Brief Summary: Iron is an essential micronutrient that plays a significant role in critical cellular functions in all organ systems in all species. Iron plays a fundamental role in neural development. It takes part in the myelination and synaptogenesis processes. The fetus obtains iron from the mother through the placenta and full-term infants are usually born with ample amounts of body iron. However, there are certain conditions which can negatively affect the fetal iron status. These include maternal iron deficiency, prematurity, maternal diabetes mellitus, pre-eclampsia, maternal smoking, and intrauterine growth restriction during pregnancy. These conditions have been associated with decreased iron transfer to the fetus and often lead to in utero iron deficiency. The negative iron balance results in hierarchical loss of tissue iron where iron depletion occurs in the brain before it occurs in the red blood cells. The negative iron status that occurs when brain iron may be depleted but red blood cells are not affected is termed as latent iron deficiency. Latent Iron Deficiency can be defined as serum ferritin level between 11 to 75 ng/ml with normal hemoglobin.Such infants could exhaust their iron stores much earlier and become iron deficient before 6 months of age . Identification of such infants becomes important as in utero LID can result in delayed neuronal maturation and abnormal neurological outcomes during childhood.

As very little is known about the incidence of in utero LID and the risk factors associated with it,we are aiming to determine the incidence of LID in pregnancy with and without risk factors for poor in utero iron status through our study.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 650

Inclusion Criteria

All new born babies (NBB) born at CHAF Bangalore with gestational age â‰¥ 34 weeks.

Exclusion Criteria

1.New born babies with gestational age < 34 weeks.
2.Any maternal h/o hemoglobinopathies or h/o blood transfusion during the current pregnancy.
3.Any maternal h/o third trimester infection/ chorioamnionitis.
4.NBB with chromosomal diseases or severe craniofacial anomalies 5.NBB with bleeding disorders/ congenital anemias/ hemolytic diseases.
6.NBB with obvious iron deficiency (serum ferritin <11 ng/mL).
7.Refusal of consent.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the incidence of latent iron deficiency in neonates more than 34 weeks with and without risk factors for poor in utero iron status at birth	From birth to within 72 hours of life

Secondary Outcome Measures

Name	Time	Method
To study the correlation between maternal iron status and neonatal iron status	at birth
To compare the iron status of the infant	at birth and 4-6 months of age

Trial Locations

Locations (1): Command Hospital Airforce Bangalore
🇮🇳
Bangalore, KARNATAKA, India
Command Hospital Airforce Bangalore
🇮🇳Bangalore, KARNATAKA, India
Dr Puneeth A
Principal investigator
8971106141
puneethamaresh@gmail.com