Effects of iron supplementation on neurocognitive development

Phase 3

• Conditions: Iron deficiency; E61.1; Iron deficiency.

• Registration Number: IRCT20210205050253N1
• Lead Sponsor: Sheikh Zayed Medical College / Hospital Rahim Yar Khan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

1.Patients born between 34 and 36weeks gestational age.
2.Infants older than 1 month of age and tolerating enteral feeds
3.Parental permission was obtained prior to the start of the study.

Exclusion Criteria

1.Significant intrauterine growth limitation, birth weight less than 2000 g, or tiny for maternal age (<3° centile)
2.Congenital illnesses, presumed disorders, or severe congenital malformation
3.Birth asphyxia
4.Neurological and neuro-sensory disorders, cerebral anomalies, or hematologic disorders.
5.Infants having a history of any blood transfusion will be excluded.
6.Parents gave no consent
7.Unable to return for follow-up evaluation at 1 year of age.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Neurodevelopmental outcome. Timepoint: 12 months of age. 6 months after intervention. Method of measurement: 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.;1.Iron deficiency. Timepoint: 1 month, 6th month and 12th month. Method of measurement: CBC.;Length. Timepoint: 1 month, 6th month and 12th month. Method of measurement: Measuring tape.;Weight. Timepoint: 1 month, 6th month and 12th month. Method of measurement: Weight machine.