How Accurate INFANIB is Among Hospitalized Preterm Infants

April 30, 2021 updated by: Asir John Samuel

Reliability of Infant Neurological International Battery (INFANIB) Among Hospitalized Preterm Infants.

Reliability of infant neurological international battery (INFANIB) among hospitalized preterm infants will be checked. This study will mainly focus on test-retest reliability.

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Haryana
      • Ambala, Haryana, India, 133203
        • Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Stable preterm infants admitted in Neonatal intensive care unit.

Description

Inclusion Criteria:

  1. Preterm neonates.
  2. Stable neonates.

Exclusion Criteria:

  1. Unstable neonates.
  2. Neonates on respiratory assistive devices.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
INFANIB score
Time Frame: Change from score of INFANIB scale at three consecutive days.
Measuring neurodevelopmental maturity among neonates
Change from score of INFANIB scale at three consecutive days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asir John Samuel

Collaborators

Maharishi Markendeswar University (Deemed to be University)

Investigators

  • Principal Investigator: Dimple Thapar, BPT, Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 15, 2021

Primary Completion (ACTUAL)

March 30, 2021

Study Completion (ACTUAL)

April 10, 2021

Study Registration Dates

First Submitted

March 9, 2021

First Submitted That Met QC Criteria

March 13, 2021

First Posted (ACTUAL)

March 16, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 30, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMDU/IEC/1835

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preterm Infants

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe