"Iron status in moderate to late preterm babies"

Recruiting

Conditions: Preterm [premature] newborn [other],

Registration Number: CTRI/2019/03/018187

Lead Sponsor: Alok Kumar M K

Brief Summary: Iron deficiency (ID) is the most common micronutrient deficiency worldwide. Preterm neonates are a special risk group because their rapid growth leads to high iron requirement.1-4

Iron is an essential micronutrient that plays a significant role in critical cellular functions in all organ systems of growing fetus and newborn. Studies have demonstrated poor cognitive and neurodevelopment outcome and increased morbidities like growth restriction and impaired immunity in rapidly growing infants with iron deficiency.1,5 Indian mothers are iron deficient and severe deficiency may have impact on fetal iron reserve.6 Delayed cord clamping (DCC) is now practiced in most units, this improves the iron transfer to babies at birth.7 However, iron excess may also have detrimental effects.1

Preterm infants are at increased risk of developing iron deficiency in early infancy as compared to term babies. For Very Low birth weight (VLBW) babies and babies with birth gestation <32weeks, there are definite evidence based recommendations regarding oral iron supplementation. There is paucity of data on routine iron supplementation in moderate to late preterm babies (MLP). Most recommendations are extrapolated from research on VLBW babies. Iron deficiency and iron excess (IE) can both be harmful; hence, there is a need to evaluate the appropriateness of routine oral iron supplementation.5

In our prospective study, we aim to evaluate the iron status of MLP at the age of 14-16 weeks age, while on standard oral iron supplementation (2mg/kg/day starting at 6 weeks of life). We also wish to evaluate the predictors of ID and impact of Iron status on growth profile and development in MLP.

Inborn babies with birth gestation from 32 weeks to 36 weeks (MLP) will be eligible. Serum ferritin (SF) will be used as the measure of iron status in the body. The perinatal iron status will be measured as SF levels within 2 weeks of birth. All the babies will be started on iron supplementation (2mg/kg/day) at 6 weeks. We will evaluate the iron status (ID/IE) at 14-16 weeks while on standard oral iron supplementation.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 152

Inclusion Criteria

Inborn neonates with gestation age between 32 weeks to 36 weeks (moderate to late preterm).

Exclusion Criteria

Blood transfusion within 6 weeks of birth 2.
Babies who underwent major surgery within 6 weeks of birth 4.
Babies with twin to twin transfusion (monochorionic monoamniotic twins) 5.
Sick babies who are not stable within 2 weeks of life.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of Moderate to late preterm babies having ID/IE at 14-16 weeks age while on standard iron supplementation.	4 months

Secondary Outcome Measures

Name	Time	Method
Proportion of Moderate to late preterm babies with Iron deficiency anemia.	4 months
Predictors of Iron deficiency and Anemia	4 months
Proportion of MLP with growth parameters -2 Z score as per intergrowth charts.	4 months
Proportion of MLP having abnormal General Movement Assessment at 14-16 weeks.	4 months
Iron status and Development outcome.	1 year

Trial Locations

Locations (1): KIMS hospital, Trinandrum
🇮🇳
Thiruvananthapuram, KERALA, India
KIMS hospital, Trinandrum
🇮🇳Thiruvananthapuram, KERALA, India
Alok Kumar M K
Principal investigator
9986042757
alokmk1988@gmail.com