Clinical Trials Logo
  1. Home
  2. Preterm Infants
  3. NCT04800328
  4. Details
NCT04800328 Clinical Trial

How Accurate INFANIB is Among Hospitalized Preterm Infants

Preterm Infants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04800328
Other study ID # MMDU/IEC/1835
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 15, 2021
Est. completion date April 10, 2021

Study information
Verified date April 2021
Source Maharishi Markendeswar University (Deemed to be University)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date April 10, 2021
Est. primary completion date March 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 28 Days
Eligibility Inclusion Criteria: 1. Preterm neonates. 2. Stable neonates. Exclusion Criteria: 1. Unstable neonates. 2. Neonates on respiratory assistive devices.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
India Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital Ambala Haryana

Sponsors (2)
Lead Sponsor Collaborator
Asir John Samuel Maharishi Markendeswar University (Deemed to be University)

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary INFANIB score Measuring neurodevelopmental maturity among neonates Change from score of INFANIB scale at three consecutive days.
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02159534 - Primebrain Stimulation N/A
Recruiting NCT01813682 - Effect of Iron-fortified TPN on Preterm Infants Anemia N/A
Not yet recruiting NCT01615523 - Executive Function in Preterm Born Children: An Integrative Approach From Genetics to Brain Function N/A
Completed NCT02103777 - High Versus Low Dose of Caffeine for Apnea of Prematurity Phase 3
Recruiting NCT06201962 - Effect of Massage and Foot Reflexology on Newborns' Sleep N/A
Completed NCT05230706 - Light/Dark Cycle Promotes Weight Gain in Preterm Infants N/A
Recruiting NCT05138276 - Effect of Autologous Cord Blood Mononuclear Cells for Digestive System in Preterm Neonates Early Phase 1
Terminated NCT01430832 - Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum
Not yet recruiting NCT02872350 - Prognostic Contribution of Abdominal Ultrasound in Necrotizing Enterocolitis in Preterm Infants Less Than 33SA. N/A
Recruiting NCT01786759 - Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion Phase 4
Completed NCT00838474 - The Effect of Music by Mozart on Energy Expenditure in Growing Preterm Infants N/A
Completed NCT05656677 - Parental Involvement in Pain Reducing Measures N/A
Active, not recruiting NCT01487187 - The Effect of Cord Milking on Hemodynamic Status of Preterm Infants N/A
Completed NCT00838188 - Energy Expenditure in Breast and Bottle Feeding Preterm Infants Fed Their Mother's Breast Milk N/A
Recruiting NCT03121781 - Diaphragm Electrical Activity of Preterm Infants on nCPAP With Binasal Prongs Versus RAM Cannula N/A
Completed NCT02770976 - Respiratory Pattern During Neurally Adjusted Ventilator Assist (NAVA) in Preterm Infants N/A
Completed NCT01841268 - Skin Lipid Profiles in Term and Preterm Infants
Not yet recruiting NCT00320840 - Internal and Familial Resources and Motherhood. Follow Up of Mothers With Twins and Preterm Infants Versus Mothers With Single Full Term Infants N/A
Completed NCT01083303 - Weaning Preterm Infants at 1500 Grams From Incubators N/A
Completed NCT00707837 - Nutritional Study in Preterm Infants Phase 3