- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04324957
Neonatal Cardio-Pulmonary Outcome Measure (N-COM)
Scale Development ,Content Validation and Reliability Testing of Neonatal Cardio-pulmonary Outcome Measure (N-COM) in Neonates Admitted in Neonatal Intensive Care Unit
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Haryana
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Mullana, Haryana, India, 133207
- Maharishi Markandeshwar (M.M) Hospital, Mullana, Ambala, Haryana
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Preterm and full term neonates with cardio-pulmonary conditions Stable Neonates
Exclusion Criteria:
- Neonates with severe disability Parents who are not wiling to participate their newborn in study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, PRE INTERVENTION, 1 year POST INTERVENTION
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pooja Mehra, BPT, (MPT), Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Congenital Abnormalities
- Infant, Newborn, Diseases
- Cardiovascular Abnormalities
- Infant, Premature, Diseases
- Heart Defects, Congenital
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
Other Study ID Numbers
- MMDU/IEC/1524
- U1111-1249-3550 (OTHER: Universal Trial Number (UTN) by WHO ICTRP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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