Neonatal Cardio-Pulmonary Outcome Measure
Condition: Congenital Heart Defect; Respiratory Distress Syndrome in Premature Infant
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Heart Defects, Congenital
Study type: Observational [Patient Registry]

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).
      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.
    

Intervention name(s): Neonatal cardio-pulmonary outcome measure used to assess cardio-pulmonary status
Intervention type(s): Other
Intervention description(s): Neonatal cardio-pulmonary outcome measure will be used to assess overall status of pulmonaryand cardio-vascular system
Observational model: Other
Time perspective: Other
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.
      
Keywords: Heart defects; Pulmonary function test; Newborns