NCT05361213

Brief Summary

To explore the association among anthropometric parameters and neuromotor behaviour in neonates for early identification and prediction of later neuromotor deficit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 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

Study Start

First participant enrolled

August 12, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2022

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

March 31, 2022

Last Update Submit

April 28, 2022

Conditions

Keywords

Correlation; infants; muscles; weight; length

Outcome Measures

Primary Outcomes (4)

  • Neuromotor behaviour

    INFANIB scoring from 14- 70 score was documented

    at the baseline, single time on day first of assessment

  • Demographic dimension

    Weight (kg) measured at baseline

    at the baseline demographic dimension measured, single time on day first

  • Demographic dimensions

    length (cm) and occipitofrontal circumference (cm) measured at baseline

    at the baseline demographic dimension measured, single time on day first

  • Anthropometric measurement

    Both the sides forearm (cm), midarm (cm), thigh (cm) and calf circumference (cm) measurement

    Anthropometry was documented single time on same day

Eligibility Criteria

Age28 Weeks - 42 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Both term and preterm neonates from level III B NICU

You may qualify if:

  • Neonates born between ≥28 weeks and ≤ 42 weeks of gestation
  • Birth weight between 1500 and 3000 grams
  • Neonates are born under all the classifications of Fenton growth charts (SGA, AGA and LGA)
  • Stable Hemodynamics
  • Free from infection
  • Stable vitals

You may not qualify if:

  • Dermal conditions
  • Chromosomal abnormalities
  • History of surgery
  • Neural tube defect
  • Cardiac abnormally

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jaishree

Ambāla, Haryana, 133207, India

Location

MeSH Terms

Conditions

Cerebral PalsyAutistic DisorderBody Weight

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAutism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Asir John Samuel, PhD

    Maharshi Markandeshwar institute of physiotherapy and rehabilitation, mullana, ambala, india

    STUDY DIRECTOR
  • Sunanda Bhowmik, MPT

    Maharshi Markandeshwar institute of physiotherapy and rehabilitation, mullana, ambala, india

    STUDY CHAIR
  • Jaishree Rai, (MPT)

    Maharshi Markandeshwar institute of physiotherapy and rehabilitation, mullana, ambala, india

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Maharishi Markandeshwar Institute of physiotherapy and rehabilitation

Study Record Dates

First Submitted

March 31, 2022

First Posted

May 4, 2022

Study Start

August 12, 2021

Primary Completion

March 3, 2022

Study Completion

March 15, 2022

Last Updated

May 4, 2022

Record last verified: 2022-04

Locations