Clinical trial NCT04800328: How Accurate INFANIB is Among Hospitalized Preterm Infants
Official title: Reliability of Infant Neurological International Battery (INFANIB) Among Hospitalized Preterm Infants.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Infants
Keywords: Neonatal
Preterm
NICU
Newborn
INFANIB
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
Collaborators: name: Maharishi Markendeswar University (Deemed to be University)
First posted: 2021-03-16
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stable preterm infants admitted in Neonatal intensive care unit.

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

Eligibility criteria: Inclusion Criteria:

1. Preterm neonates.
2. Stable neonates.

Exclusion Criteria:

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

Primary outcomes:
measure: INFANIB score
timeFrame: Change from score of INFANIB scale at three consecutive days.
Secondary outcomes:
Other outcomes:
Locations:
city: Ambala
country: India
facility: Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital
state: Haryana
Study officials:
affiliation: Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
name: Asir J Samuel, MPT, PhD
role: STUDY_CHAIR
affiliation: Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
name: Dimple Thapar, BPT
role: PRINCIPAL_INVESTIGATOR
References: