Neonatal Cardio-Pulmonary Outcome Measure (N-COM)

April 3, 2021 updated by: Asir John Samuel

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.

Study Overview

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

Observational

Enrollment (Actual)

30

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

    • Haryana
      • Mullana, Haryana, India, 133207
        • Maharishi Markandeshwar (M.M) Hospital, Mullana, Ambala, Haryana

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

4 weeks to 1 month (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

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

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
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

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

Investigators

  • Principal Investigator: Pooja Mehra, BPT, (MPT), Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation

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 31, 2020

Primary Completion (ACTUAL)

March 25, 2021

Study Completion (ACTUAL)

March 31, 2021

Study Registration Dates

First Submitted

March 6, 2020

First Submitted That Met QC Criteria

March 26, 2020

First Posted (ACTUAL)

March 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 3, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Congenital Heart Defect

Clinical Trials on Neonatal cardio-pulmonary outcome measure used to assess cardio-pulmonary status

3
Subscribe