Neonatal Cardio-Pulmonary Outcome Measure

NCT04324957 | Completed DMC

• 2 other identifiers: MMDU/IEC/1524U1111-1249-3550
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Heart Defect; Respiratory Distress Syndrome in Premature Infant

Keywords

Heart defects; Pulmonary function test; Newborns

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, PRE INTERVENTION, 1 year POST INTERVENTION

Interventions

Neonatal cardio-pulmonary outcome measure used to assess cardio-pulmonary status OTHER

Neonatal cardio-pulmonary outcome measure will be used to assess overall status of pulmonaryand cardio-vascular system

Eligibility Criteria

• Age: 28 Days - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Preterm and full term neonates with cardio-pulmonary conditions Stable Neonates

You may not qualify if:

• Neonates with severe disability Parents who are not wiling to participate their newborn in study

Sponsors & Collaborators

• Asir John Samuel: lead

Study Sites (1)

Maharishi Markandeshwar (M.M) Hospital, Mullana, Ambala, Haryana

Mullana, Haryana, 133207, India

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Asir J Samuel, MPT, PhD

  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

  STUDY CHAIR

• Pooja Mehra, BPT, (MPT)

  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Neha Sharma, MPT

  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 27, 2020
• Study Start: August 31, 2020
• Primary Completion: March 25, 2021
• Study Completion: March 31, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

IN (1)