Preterm InfantsNCT04800328
How Accurate INFANIB is Among Hospitalized Preterm Infants
An observational study of Preterm Infants, run by Asir John Samuel at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Preterm Infants
- How many people
- 12 participants
- Where
- 1 siteIndia
- Study dates
- 15 Mar 2021to 10 Apr 2021
- 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 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Stable preterm infants admitted in Neonatal intensive care unit.
Who may be able to join
- Preterm neonates.
- Stable neonates.
Who cannot join
- Unstable neonates.
- Neonates on respiratory assistive devices.
Trial locations and contacts
1 site in 1 country.
India1 site
Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital
Ambāla, Haryana, 133203
About this study
Official title: Reliability of Infant Neurological International Battery (INFANIB) Among Hospitalized Preterm Infants.
Reliability of infant neurological international battery (INFANIB) among hospitalized preterm infants will be checked. This study will mainly focus on test-retest reliability.
Read the detailed 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.
- Conditions
- Preterm Infants
- Keywords
- Neonatal, Preterm, NICU, Newborn, INFANIB
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
INFANIB score
Measuring neurodevelopmental maturity among neonates
Measured: Change from score of INFANIB scale at three consecutive days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start15 Mar 2021
- Primary completion30 Mar 2021
- Study completion10 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies 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
- Other
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asir John Samuel
- Sponsor type
- University, hospital or other
- Collaborators
- Maharishi Markendeswar University (Deemed to be University)
- Responsible party
- Sponsor-investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Asir J Samuel, MPT, PhD, Study chair, Maharishi Markandeshwar Institute of Physiotherapy and RehabilitationDimple Thapar, BPT, Principal investigator, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800328
- Sponsor's protocol ID
- MMDU/IEC/1835
- Status last verified
- Apr 2021
- First submitted
- 9 Mar 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Infant Neurological International Battery (INFANIB) Among Hospitalized Preterm Infants.
- ClinicalTrials.gov ID
- NCT04800328
- Acronym / sponsor ID
- MMDU/IEC/1835
- Conditions
- Preterm Infants
- Keywords
- Neonatal, Preterm, NICU, Newborn, INFANIB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Collaborators
- Maharishi Markendeswar University (Deemed to be University)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 16 Mar 2021 (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.
Reliability of infant neurological international battery (INFANIB) among hospitalized preterm infants will be checked. This study will mainly focus on test-retest reliability.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Stable preterm infants admitted in Neonatal intensive care unit.
Key inclusion criteria (2 listed)
- Preterm neonates.
- Stable neonates.
Key exclusion criteria (2 listed)
- Unstable neonates.
- Neonates on respiratory assistive devices.
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
INFANIB score
Time frame: Change from score of INFANIB scale at three consecutive days.
Measuring neurodevelopmental maturity among neonates
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 3 May 2021.
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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 J Samuel, MPT, PhD study chair
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Dimple Thapar, BPT principal investigator
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
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 Preterm Infants, 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 2 inclusion and 2 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 3 May 2021. 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?
INFANIB score (time frame: Change from score of INFANIB scale at three consecutive days.). 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 3 May 2021.