Clinical Trial on Cerebral Palsy, Autism or Other Neuromotor Behavior Abnormalities Correlation With Anthropometry - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Cerebral Palsy, Autism or Other Neuromotor Behavior Abnormalities Correlation With Anthropometry

Detailed Description

The association between anthropometric (birth weight, length and occipitofrontal circumference) measurement and hands-on measurement of above mentioned anthropometric dimensions and demographic dimension (bilateral forearm, midarm, calf and thigh) with neuromotor behaviour were explored.

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

India
- Haryana
  - Ambala, Haryana, India, 133207
    - Jaishree

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 9 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Both term and preterm neonates from level III B NICU

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuromotor behaviour Time Frame: at the baseline, single time on day first of assessment	INFANIB scoring from 14- 70 score was documented	at the baseline, single time on day first of assessment
Demographic dimension Time Frame: at the baseline demographic dimension measured, single time on day first	Weight (kg) measured at baseline	at the baseline demographic dimension measured, single time on day first
Demographic dimensions Time Frame: at the baseline demographic dimension measured, single time on day first	length (cm) and occipitofrontal circumference (cm) measured at baseline	at the baseline demographic dimension measured, single time on day first
Anthropometric measurement Time Frame: Anthropometry was documented single time on same day	Both the sides forearm (cm), midarm (cm), thigh (cm) and calf circumference (cm) measurement	Anthropometry was documented single time on same day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asir John Samuel

Investigators

Study Director: Asir John Samuel, PhD, Maharshi Markandeshwar institute of physiotherapy and rehabilitation, mullana, ambala, india
Study Chair: Sunanda Bhowmik, MPT, Maharshi Markandeshwar institute of physiotherapy and rehabilitation, mullana, ambala, india
Principal Investigator: Jaishree Rai, (MPT), Maharshi Markandeshwar institute of physiotherapy and rehabilitation, mullana, ambala, india

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 12, 2021

Primary Completion (ACTUAL)

March 3, 2022

Study Completion (ACTUAL)

March 15, 2022

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

April 28, 2022

First Posted (ACTUAL)

May 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)