NCT04800328

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2021

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

15 days

First QC Date

March 9, 2021

Last Update Submit

April 30, 2021

Conditions

Preterm Infants

Keywords

NeonatalPretermNICUNewbornINFANIB

Outcome Measures

Primary Outcomes (1)

  • INFANIB score

    Measuring neurodevelopmental maturity among neonates

    Change from score of INFANIB scale at three consecutive days.

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Stable preterm infants admitted in Neonatal intensive care unit.

You may qualify if:

  • Preterm neonates.
  • Stable neonates.

You may not qualify if:

  • Unstable neonates.
  • Neonates on respiratory assistive devices.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital

Ambāla, Haryana, 133203, India

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Asir J Samuel, MPT, PhD

    Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

    STUDY CHAIR

  • Dimple Thapar, BPT

    Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 16, 2021

Study Start

March 15, 2021

Primary Completion

March 30, 2021

Study Completion

April 10, 2021

Last Updated

May 3, 2021

Record last verified: 2021-04

Locations

IN(1)