Viewing Study NCT04800328



Ignite Creation Date: 2024-05-06 @ 3:55 PM
Last Modification Date: 2024-10-26 @ 1:59 PM
Study NCT ID: NCT04800328
Status: COMPLETED
Last Update Posted: 2021-05-03
First Post: 2021-03-09

Brief Title: How Accurate INFANIB is Among Hospitalized Preterm Infants
Sponsor: Asir John Samuel
Organization: Maharishi Markendeswar University Deemed to be University

Study Overview

Official Title: Reliability of Infant Neurological International Battery INFANIB Among Hospitalized Preterm Infants
Status: COMPLETED
Status Verified Date: 2021-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Reliability of infant neurological international battery INFANIB among hospitalized preterm infants will be checked This study will mainly focus on test-retest reliability
Detailed Description: Background NICU is a specialised intensive care unit that treats and cares for premature or critically ill newborn babies A special category of high-risk babies consists of premature infants Their motor growth differs from that of healthy full-term infants and their occurrence of motor disorders is greater The outcome of neuromotor disorders can be substantially changed by treatments during the first year of life So in order to detect these neuromotor disorder there must be a reliable screening tool present Hence in this study we will check reliability of INFANIB

Purpose Reliability of INFANIB among hospitalized preterm infants Methodology It will be an observational study and will be carried out in Neonatal Intensive Care Unit NICU The study will recruit preterm infants that are stable and are present without any respiratory assistive devices

INFANIB screening tool will be performed on these infants It has 20 items that measure the state of the infant for body tone and posture primitive reflexes and French angles in the supine prone sitting standing and suspended position upto 18 months But we will take only preterm infants so only 14 items will be assessed and infants will be scored accordingly The main focus will be on test- retest reliability

Discussion A similar research has been carried out in Iran and China that established that reliability of INFANIB is excellent Another research was carried out in India that stated INFANIBs reliability to be low So this study is required to be carried out in India to know the actual results

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None