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How Accurate INFANIB is Among Hospitalized Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04800328
Recruitment Status : Completed
First Posted : March 16, 2021
Last Update Posted : May 3, 2021
Sponsor:
Collaborator:
Maharishi Markendeswar University (Deemed to be University)
Information provided by (Responsible Party):
Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)

Study Description
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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.

Condition or disease
Preterm Infants

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 Design
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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Other
Time Perspective: Other
Official Title: Reliability of Infant Neurological International Battery (INFANIB) Among Hospitalized Preterm Infants.
Actual Study Start Date : March 15, 2021
Actual Primary Completion Date : March 30, 2021
Actual Study Completion Date : April 10, 2021
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. INFANIB score [ Time Frame: Change from score of INFANIB scale at three consecutive days. ]
    Measuring neurodevelopmental maturity among neonates


Eligibility Criteria
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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Stable preterm infants admitted in Neonatal intensive care unit.
Criteria

Inclusion Criteria:

  1. Preterm neonates.
  2. Stable neonates.

Exclusion Criteria:

  1. Unstable neonates.
  2. Neonates on respiratory assistive devices.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04800328


Locations
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India
Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital
Ambala, Haryana, India, 133203
Sponsors and Collaborators
Asir John Samuel
Maharishi Markendeswar University (Deemed to be University)
Investigators
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Study Chair: Asir J Samuel, MPT, PhD Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Principal Investigator: Dimple Thapar, BPT Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
More Information
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Responsible Party: Asir John Samuel, Associate Professor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markendeswar University (Deemed to be University)
ClinicalTrials.gov Identifier: NCT04800328    
Other Study ID Numbers: MMDU/IEC/1835
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asir John Samuel, Maharishi Markendeswar University (Deemed to be University):
Neonatal
Preterm
NICU
Newborn
INFANIB
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications