To study the effects of kangaroo mother care on heart function in preterm babies

Not yet recruiting

• Conditions: Measurement and Monitoring,

• Registration Number: CTRI/2025/03/083657
• Lead Sponsor: Bharati Vidyapeeth Deemed University Medical College Pune Maharashtra

Brief Summary

Every preterm newborn in their NICU stay undergoes KMC also called as Kangaroo Mother Care(Skin-to-skin care). KMC provides many benefits to the baby such as more stable breathing patterns, fewer bradycardic episodes, and reduced periodic breathing. Brief exposure to skin-to-skin contact has also been linked to favourable infant and maternal outcomes, including a better stress response, improved sleep organization, and enhanced cognitive control. There are also long-term benefits too. In our study we want to look into how the cardiac hemodynamics changes and improves after KMC by doing an echocardiography before and after KMC is being given.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-03-27
• Study Start: 2025-07-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1.Preterm neonates between 28 and 37 weeks of corrected gestational age, who are clinically stable, and have had atleast more than 3 days of skin-to-skin care by caregivers 2.
• Preterm neonates of more than 7 days of age 3.
• Babies on minimal non-invasive respiratory support (CPAP less than 6 and FiO2 less than 25%, or HFNC less than 5 litres/min and FiO2 less than 25%).

Exclusion Criteria

• Neonates with the following clinical conditions will be excluded from the study: 1.
• Congenital heart disease 2.
• Major congenital malformations 3.
• Birth asphyxia 4.
• Intraventricular hemorrhage (grade 3 or more) 5.
• Neonates on inotropic support or received inotropes in last 48 hours at the time of enrolment 6.
• Neonates on sedatives currently or in the last 72 hours of enrolment 7.
• Haemodynamically significant patent ductus arteriosus (HsPDA) at the time of enrolment, as defined by clinical team 8.
• PPHN (Persistent Pulmonary Hypertension of Newborn).

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To assess the percentage change in right ventricle and left ventricle cardiac output before and after skin-to-skin care in preterm neonates.	Before and after echocardiography
2. To assess the percentage changes in right ventricle and left ventricle systolic function before and after skin-to-skin care in preterm neonates.	Before and after echocardiography

Secondary Outcome Measures

Name	Time	Method
To assess changes in cardio-physiological parameters before and after skin-to-skin care (HR, dips in oxygen saturations of more than 5% from baseline, axillary temperature) in preterm neonates	Before and after echocardiography

Trial Locations

Locations (1)

Bharati Hospital, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Bharati Hospital, Pune

🇮🇳Pune, MAHARASHTRA, India

Dr Rupam Das

Principal investigator

6000622460

rd.rupam21@gmail.com