Cerebral Palsy, Autism or Other Neuromotor Behavior Abnormalities Correlation With AnthropometryNCT05361213
Is There Any Correlation Among Neonates Anthropometry and Neuromotor Behaviour
An observational study of Cerebral Palsy, Autism or Other Neuromotor Behavior Abnormalities Correlation With Anthropometry, run by Asir John Samuel at 1 site in India.
Trial summary
To explore the association among anthropometric parameters and neuromotor behaviour in neonates for early identification and prediction of later neuromotor deficit. Read more about this study
- Who is it for?
- Ages 28 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Autism or Other Neuromotor Behavior Abnormalities Correlation With Anthropometry
- How many people
- 54 participants
- Where
- 1 siteIndia
- Study dates
- 12 Aug 2021to 15 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Both term and preterm neonates from level III B NICU
Who may be able to join
- 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
Who cannot join
- Dermal conditions
- Chromosomal abnormalities
- History of surgery
- Neural tube defect
- Cardiac abnormally
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Among Anthropometric Parameters and Neuromotor Behaviour in Neonates
To explore the association among anthropometric parameters and neuromotor behaviour in neonates for early identification and prediction of later neuromotor deficit.
Read the 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.
- Conditions
- Cerebral Palsy, Autism or Other Neuromotor Behavior Abnormalities Correlation With Anthropometry
- Keywords
- Correlation; infants; muscles; weight; length
- Medical subject headings
- Cerebral Palsy, Autistic Disorder, Body Weight
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromotor behaviour
INFANIB scoring from 14- 70 score was documented
Measured: at the baseline, single time on day first of assessment
Demographic dimension
Weight (kg) measured at baseline
Measured: at the baseline demographic dimension measured, single time on day first
Demographic dimensions
length (cm) and occipitofrontal circumference (cm) measured at baseline
Measured: 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
Measured: Anthropometry was documented single time on same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start12 Aug 2021
- Primary completion3 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, Autism or Other Neuromotor Behavior Abnormalities Correlation With AnthropometryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asir John Samuel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Asir John Samuel, PhD, Study director, Maharshi Markandeshwar institute of physiotherapy and rehabilitation, mullana, ambala, indiaSunanda Bhowmik, MPT, Study chair, Maharshi Markandeshwar institute of physiotherapy and rehabilitation, mullana, ambala, indiaJaishree Rai, (MPT), Principal investigator, Maharshi Markandeshwar institute of physiotherapy and rehabilitation, mullana, ambala, india
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361213
- Sponsor's protocol ID
- MMDU/IEC/1924
- Status last verified
- Apr 2022
- First submitted
- 31 Mar 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Among Anthropometric Parameters and Neuromotor Behaviour in Neonates
- ClinicalTrials.gov ID
- NCT05361213
- Acronym / sponsor ID
- MMDU/IEC/1924
- Conditions
- Cerebral Palsy, Autism or Other Neuromotor Behavior Abnormalities Correlation With Anthropometry
- Keywords
- Correlation; infants; muscles; weight; length
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the association among anthropometric parameters and neuromotor behaviour in neonates for early identification and prediction of later neuromotor deficit.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 28 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Both term and preterm neonates from level III B NICU
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Dermal conditions
- Chromosomal abnormalities
- History of surgery
- Neural tube defect
- Cardiac abnormally
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neuromotor behaviour
Time frame: at the baseline, single time on day first of assessment
INFANIB scoring from 14- 70 score was documented
Demographic dimension
Time frame: at the baseline demographic dimension measured, single time on day first
Weight (kg) measured at baseline
Demographic dimensions
Time frame: at the baseline demographic dimension measured, single time on day first
length (cm) and occipitofrontal circumference (cm) measured at baseline
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asir John Samuel, PhD study director
Maharshi Markandeshwar institute of physiotherapy and rehabilitation, mullana, ambala, india
Sunanda Bhowmik, MPT study chair
Maharshi Markandeshwar institute of physiotherapy and rehabilitation, mullana, ambala, india
Jaishree Rai, (MPT) principal investigator
Maharshi Markandeshwar institute of physiotherapy and rehabilitation, mullana, ambala, india
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, Autism or Other Neuromotor Behavior Abnormalities Correlation With Anthropometry, run by Asir John Samuel at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuromotor behaviour (time frame: at the baseline, single time on day first of assessment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.