Congenital Heart DefectN-COMNCT04324957
Neonatal Cardio-Pulmonary Outcome Measure
An observational study of Congenital Heart Defect and Respiratory Distress Syndrome in Premature Infant, run by Asir John Samuel at 1 site in India.
Trial summary
Neonatal Cardio-Pulmonary outcome measure (N-COM) will be used to assess the overall status of pulmonary and cardiac vascular system of neonates in Neonatal Intensive Care Unit (NICU). Read more about this study
- Who is it for?
- Ages 28 days to 1 month
- Conditions the study is for
- Congenital Heart Defect, Respiratory Distress Syndrome in Premature Infant
- What is being tested?
- Neonatal cardio-pulmonary outcome measure used to assess cardio-pulmonary status
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 31 Aug 2020to 31 Mar 2021
- How long will I take part?
- 1 Week
- 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 days to 1 month
- All sexes
- No healthy volunteers
- Child
Study population: Neonates who are suffering from cardio-pulmonary conditions will be taken in the study such as- Respiratory distress syndrome, Pneumonia, Congenital heart defects etc.
Who may be able to join
- Preterm and full term neonates with cardio-pulmonary conditions Stable Neonates
Who cannot join
- Neonates with severe disability Parents who are not wiling to participate their newborn in study
Trial locations and contacts
1 site in 1 country.
India1 site
Maharishi Markandeshwar (M.M) Hospital, Mullana, Ambala, Haryana
Mullana, Haryana, 133207
About this study
Official title: Scale Development ,Content Validation and Reliability Testing of Neonatal Cardio-pulmonary Outcome Measure (N-COM) in Neonates Admitted in Neonatal Intensive Care Unit
Neonatal Cardio-Pulmonary outcome measure (N-COM) will be used to assess the overall status of pulmonary and cardiac vascular system of neonates in Neonatal Intensive Care Unit (NICU). There are many scales available which are helpful for assessing behavior, pain, and neurological status of neonates but there is no scale available till now which can help to assess cardio-pulmonary status of neonates.
Read the detailed description
Background:
Neonatal Intensive care unit (NICU) is exclusively created to treat premature and fragile neonates. The neonates with intrauterine growth limitations with congenital heart defects and respiratory diseases are at increased risk of mortality. There are several scales to assess pain, behaviour, motor changes, growth and other components of neonates. In the past, no scale is available to evaluate the cardio-pulmonary status of the neonates in NICU.
Objectives:
The objective of the study is to develop an outcome measure for checking the cardio-pulmonary status of the neonate in the Neonatal Intensive care units (NICU), as Neonatal cardio-pulmonary outcome measure (N-COM) and to validate the domains of the scale, to check the reliability and minimum desirable change (MCID).
Methods:
This study includes mainly four stages. In the first stage, different domains will be developed for the scale (N-COM) and scale will be sent for content validation. The domains of the scale will be made through different scales and the items will be selected from previous scales and from interview with medical personal working in NICU.
The lacking domains in the previous scales will be noted. The items will be evaluated by expert panel, undergo revision and pilot testing will be done. On the basis of acceptance, the pilot testing will undergo for final revision. In the second stage, the content validation of the items will be done. The test re-test reliability and inter-rater reliability will be done in this stage. In the third stage, the standard error of measurement (SEM) will be determined and minimal detectable change (MCID) at 95% Confidence Interval (CI) will be established for the scale.
Data analysis:
The content validity will be estimated by Item-content validity index (I-CVI) and scale-content validity index (S-CVI). The items and domains in the N-COM scale will undergo intra-rater and test-retest reliability testing by intra-class correlation coefficient (ICC) and criterion-related validity by Spearman Rank correlation coefficient.
Discussion:
The Neonatal cardio-pulmonary outcome measure (N-COM) will be the first scale which will help to assess respiratory and cardiac problems in the neonates. This scale N-COM will provide the general status of the cardio-pulmonary system of neonates. This scale will help to document the pre -intervention and post-intervention changes in the cardio-pulmonary system of neonates. As the item and domain development of this scale includes both systematic literature and structural interview, missed out items will be minimized. This will make this scale best outcome measure for documenting patient outcome in India.
- Being tested
- Neonatal cardio-pulmonary outcome measure used to assess cardio-pulmonary status
- Keywords
- Heart defects, Pulmonary function test, Newborns
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neonatal cardio-pulmonary outcome measure used to assess cardio-pulmonary statusOther
Neonatal cardio-pulmonary outcome measure will be used to assess overall status of pulmonaryand cardio-vascular system
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neonatal Cardio-pulmonary outcome measure (N-COM)
Changes in pre and post Neonatal-cardio-pulmonary outcome measure (N-COM) will be noted. In pulmonary system, cyanosis (peripheral and central cyanosis), nasal grunting, chest retractions, respiratory rate, SPO2, nasal flaring, chest symmetry etc will be checked. In the cardiovascular system, heart rate, pulse rate, congenital heart defects, chest symmetry, heart sounds etc will be checked.
Measured: Baseline, PRE INTERVENTION, 1 year POST INTERVENTION
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start31 Aug 2020
- Primary completion25 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DefectStudies 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
- 30 participants (actual)
- Target duration
- 1 Week
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 J Samuel, MPT, PhD, Study chair, Maharishi Markandeshwar Institute of Physiotherapy and RehabilitationPooja Mehra, BPT, (MPT), Principal investigator, Maharishi Markandeshwar Institute of Physiotherapy and RehabilitationNeha Sharma, MPT, Study director, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324957
- Sponsor's protocol ID
- MMDU/IEC/1524
- Other IDs
- U1111-1249-3550
- Acronym
- N-COM
- Status last verified
- Apr 2021
- First submitted
- 6 Mar 2020
- Last updated
- 8 Apr 2021
- 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 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scale Development ,Content Validation and Reliability Testing of Neonatal Cardio-pulmonary Outcome Measure (N-COM) in Neonates Admitted in Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04324957
- Acronym / sponsor ID
- N-COM / MMDU/IEC/1524
- Keywords
- Heart defects, Pulmonary function test, Newborns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 27 Mar 2020 (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.
Neonatal Cardio-Pulmonary outcome measure (N-COM) will be used to assess the overall status of pulmonary and cardiac vascular system of neonates in Neonatal Intensive Care Unit (NICU). There are many scales available which are helpful for assessing behavior, pain, and neurological status of neonates but there is no scale available till now which can help to assess cardio-pulmonary status of neonates.
Detailed description
Background:
Neonatal Intensive care unit (NICU) is exclusively created to treat premature and fragile neonates. The neonates with intrauterine growth limitations with congenital heart defects and respiratory diseases are at increased risk of mortality. There are several scales to assess pain, behaviour, motor changes, growth and other components of neonates. In the past, no scale is available to evaluate the cardio-pulmonary status of the neonates in NICU.
Objectives:
The objective of the study is to develop an outcome measure for checking the cardio-pulmonary status of the neonate in the Neonatal Intensive care units (NICU), as Neonatal cardio-pulmonary outcome measure (N-COM) and to validate the domains of the scale, to check the reliability and minimum desirable change (MCID).
Methods:
This study includes mainly four stages. In the first stage, different domains will be developed for the scale (N-COM) and scale will be sent for content validation. The domains of the scale will be made through different scales and the items will be selected from previous scales and from interview with medical personal working in NICU.
The lacking domains in the previous scales will be noted. The items will be evaluated by expert panel, undergo revision and pilot testing will be done. On the basis of acceptance, the pilot testing will undergo for final revision. In the second stage, the content validation of the items will be done. The test re-test reliability and inter-rater reliability will be done in this stage. In the third stage, the standard error of measurement (SEM) will be determined and minimal detectable change (MCID) at 95% Confidence Interval (CI) will be established for the scale.
Data analysis:
The content validity will be estimated by Item-content validity index (I-CVI) and scale-content validity index (S-CVI). The items and domains in the N-COM scale will undergo intra-rater and test-retest reliability testing by intra-class correlation coefficient (ICC) and criterion-related validity by Spearman Rank correlation coefficient.
Discussion:
The Neonatal cardio-pulmonary outcome measure (N-COM) will be the first scale which will help to assess respiratory and cardiac problems in the neonates. This scale N-COM will provide the general status of the cardio-pulmonary system of neonates. This scale will help to document the pre -intervention and post-intervention changes in the cardio-pulmonary system of neonates. As the item and domain development of this scale includes both systematic literature and structural interview, missed out items will be minimized. This will make this scale best outcome measure for documenting patient outcome in India.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 28 days to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates who are suffering from cardio-pulmonary conditions will be taken in the study such as- Respiratory distress syndrome, Pneumonia, Congenital heart defects etc.
Key inclusion criteria (1 listed)
- Preterm and full term neonates with cardio-pulmonary conditions Stable Neonates
Key exclusion criteria (1 listed)
- Neonates with severe disability Parents who are not wiling to participate their newborn in study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neonatal cardio-pulmonary outcome measure used to assess cardio-pulmonary statusNeonatal cardio-pulmonary outcome measure will be used to assess overall status of pulmonaryand cardio-vascular system | Other | – |
Primary outcome
Change in Neonatal Cardio-pulmonary outcome measure (N-COM)
Time frame: Baseline, PRE INTERVENTION, 1 year POST INTERVENTION
Changes in pre and post Neonatal-cardio-pulmonary outcome measure (N-COM) will be noted. In pulmonary system, cyanosis (peripheral and central cyanosis), nasal grunting, chest retractions, respiratory rate, SPO2, nasal flaring, chest symmetry etc will be checked. In the cardiovascular system, heart rate, pulse rate, congenital heart defects, chest symmetry, heart sounds etc will be checked.
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 8 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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
Pooja Mehra, BPT, (MPT) principal investigator
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Neha Sharma, MPT study director
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 Congenital Heart Defect and Respiratory Distress Syndrome in Premature Infant, 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 1 inclusion and 1 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 8 Apr 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?
Change in Neonatal Cardio-pulmonary outcome measure (N-COM) (time frame: Baseline, PRE INTERVENTION, 1 year POST INTERVENTION). 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 8 Apr 2021.