How Accurate INFANIB is Among Hospitalized Preterm Infants

NCT ID: NCT04800328

Last Updated: 2021-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-15

Study Completion Date

2021-04-10

Brief Summary

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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

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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 INFANIB's reliability to be low. So this study is required to be carried out in India to know the actual results.

Conditions

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Preterm Infants

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

1. Preterm neonates.
2. Stable neonates.

Exclusion Criteria

1. Unstable neonates.
2. Neonates on respiratory assistive devices.
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maharishi Markendeswar University (Deemed to be University)

OTHER

Sponsor Role collaborator

Asir John Samuel

OTHER

Sponsor Role lead

Responsible Party

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Asir John Samuel

Associate Professor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Asir J Samuel, MPT, PhD

Role: STUDY_CHAIR

Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

Dimple Thapar, BPT

Role: PRINCIPAL_INVESTIGATOR

Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

Locations

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Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital

Ambāla, Haryana, India

Site Status

Countries

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India

Other Identifiers

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MMDU/IEC/1835

Identifier Type: -

Identifier Source: org_study_id

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