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Completed

NCT Number: NCT04800328

How Accurate INFANIB is 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.

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Key information

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital

Ambāla, Haryana, 133203, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preterm neonates.
  • Stable neonates.

Exclusion criteria

  • Unstable neonates.
  • Neonates on respiratory assistive devices.

Treatment and study plan

Primary outcomes

  1. INFANIB score

    Time frame: Change from score of INFANIB scale at three consecutive days.

    Measuring neurodevelopmental maturity among neonates

Sponsors and collaborators

Lead sponsor

Asir John Samuel

Other

Collaborators

  • Maharishi Markendeswar University (Deemed to be University)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 16, 2021
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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