IRCT20210205050253N1 IRCT 2023-02-05 Sheikh Zayed Medical College / Hospital Rahim Yar Khan Effects of iron supplementation on neurocognitive development Effects of iron supplementation on neurocognitive development of children 2023-04-01 anticipated 204 Complete https://irct.ir/trial/68402 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Using a computer-generated randomization process, the infants will be randomly allocated into two groups (Group 1: iron group; Group 2: Placebo). Group A (iron group) will receive iron supplementation at 2mg/kg/day when the infant is on enteral feeds and at least one month old. It will be continued till 6 months of post-conception age. Group B will receive a placebo. At the six-month assessment, children who have not taken the research medicine more than 80% of the prescribed days will be categorized as poor complaints and removed from the research. Before participating in the randomization, all registered newborns will get a complete blood count examination at one month of age to rule out anemia. According to Jopling et al. (2009) primary parameter, the cutoff for anemia at one month of age will be hemoglobin 11 g/dL for infants 35-36 gestational age and 10.5 g/dL for infants 34 gestational age. At 6 months and 12 months post-conception, a general medical examination will be carried out to ensure conformity with the medication protocol and assessment of anthropometric measures. Haemoglobin 10.5 g/dL will be the cutoff for anemia at the 6- and 12-month assessments. All patients will be assessed for the psychomotor outcome at 12 months of age using a scale named “Portage guide to early education (PGEE)." This scale contains 5 parameters, i.e., cognition, self-help, motor, socialization, and language. The test will be stopped if the child does not fulfill seven consecutive behaviors from a PGEE scale parameter. For each scale, a mental age and a developmental quotient will be provided (DQ). The mean of the developmental quotients obtained in each of the five subscales will be used to compute the overall development quotient. If the developmental quotient is higher than 85%, between 85% and 70%, or less than 70%, it will be deemed "borderline" and indicative of developmental problems, Blinding description: Group A (iron group) will receive iron supplementation at 2mg/kg/day when the infant is on enteral feeds and at least one month old. It will be continued till 6 months of post-conception age. Group B will receive a placebo. As this is single blinded study so participants will be blinded only. 3 Iron deficiency. After getting informed consent from the parents, patients will be divided into two groups. A total of 204 cases will be included in the study for research. Group A (iron group) will receive iron supplementation at 2mg/kg/day. It will be continued till 6 months of post-conception age. Group B will receive a placebo. All patients will be assessed for the psychomotor outcome at 12 months of age using a scale named “Portage guide to early education (PGEE)." This scale contains 5 parameters, i.e., cognition, self-help, motor, socialization, and language. The test will be stopped if the child does not fulfill seven consecutive behaviors from a PGEE scale parameter.. Yes - There is a plan to make this available What will be shared: Effects of iron supplementation on neurocognitive development of children When: 2025 To whom: to all. Conditions: Portage guide to early education scale data will be shared, along with weight, length and CBC data. Where to obtain: IRCT or via email from the author How to obtain: Prior permissionfrom the author via mail Comments: