Serum Ferritin level guided vs Standard practice of oral iron supplementation in very preterm neonates hospitalized in tertiary care NICU - A Prospective randomised control superiority trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 206
- Locations
- 2
- Primary Endpoint
- Determining the optimal age (in day of life) for initiation of oral iron supplementation at the time of full feed achievement and at 2 weeks of life (whichever is later) by serum ferritin monitoring compared with the standard practice.
Study Overview
Brief Summary
•Iron deficiency in preterm infants is associated with impaired motor, cognitive, and behavioral development . Adequate iron stores are essential for normal development of the dopaminergic axis, myelination, and dendritic arborization .However, many preterm infants develop iron deficiency due to decreased stores, rapid growth, and phlebotomy losses
•Conversely, preterm infants are particularly susceptible to the pro-oxidant effects of excess circulating iron because their antioxidant systems are immature. preterm complications like bronchopulmonary dysplasia, intraventricular hemorrhage, and retinopathy of prematurity are exacerbated by excess iron intake.
•Thus, it is important to prevent both deficiency and excess by providing the optimal amount and timing of iron intake for preterm infants.
However, optimal iron intake remains controversial.-The American Academy of Pediatrics (AAP) recommends 2mg/kg/day of oral iron for human milk-fed preterm infants at 4 weeks (except for those who received transfusions),New Zealand & Australian Pediatrics society at 2- 3 weeks of age with 3 mg /kg/ day and theEuropean Society for Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) at 2 weeks of age with 2-3mg/kg/day.
European Society for Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) 2022 - 23
•Since individual iron status in VLBW infants is highly variable, depending on the number of received blood transfusions and blood losses from phlebotomy, it is recommended to follow these infants with repeated measurements of serum ferritin •If ferritin is <35–70 µg/L, the iron dose may be increased up to 3–4 (or maximum 6) mg/kg/d for a limited period.•If ferritin is >300 µg/L, which in the absence of ongoing inflammation and liver disease usually is the result of multiple blood transfusions, iron supplementation and fortification should be discontinued until serum ferritin falls below this level
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 0.00 Day(s) to 21.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •Neonates less than 32 weeks of gestational age hospitalized in NICU.
Exclusion Criteria
- •Preterm neonates whom iron supplementation is deferred because as in 1.Those with an active, culture-proven infection, or positive sepsis screen 2.A major surgical malformation of gut 3.Neonates in whom bowel resection is done 4.Neonates with Stage II and III Necrotizing enterocolitis 5.Cyanotic congenital heart disease 6.Neonates with hemoglobinopathies.
- •7.Neonates diagnosed with inflammatory conditions like hemophagocytic lymphohistiosis (HLH).
Outcomes
Primary Outcomes
Determining the optimal age (in day of life) for initiation of oral iron supplementation at the time of full feed achievement and at 2 weeks of life (whichever is later) by serum ferritin monitoring compared with the standard practice.
Time Frame: 2 weeks to 4 weeks
Secondary Outcomes
- 1.Total quantum (in mg) of oral iron supplemented during the NICU stay.(2.Number of LRBC transfusions administered during their stay in NICU.)
Investigators
Sunil Hanasi
Rainbow Childrens Hospital and Birthright . Banjara hills Road number 2 . Hyderabad