Effect of Kangaroo Care on Heart Rate Variability

Not Applicable

• Conditions: Oral Intolerance; Immaturity; Postnatal Adaptation

• Registration Number: NCT01865409
• Lead Sponsor: Fatih University

Brief Summary

Physiological processes leading to a preterm infant to be able to feed orally has not been fully understood. The investigators hypothesized that maturation of autonomic nervous system may play a major role in this process and kangaroo care may accelerate this maturation. The investigators will use heart rate variability to measure the maturation of autonomic nervous system.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-27
• Study First Submitted QC: 2013-05-27
• Study First Posted: 2013-05-30
• Study Start: 2013-06
• Status Verified: 2014-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2014-09-07
• Last Update Posted: 2014-09-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Premature infants between 32 t0 35 weeks old
• After 7 days of extra-uterine life

Exclusion Criteria

• Sepsis, infection
• Cardiac disease
• Intraventricular hemorrhage, patent ductus arteriosus, necrotizing enterocolitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
HRV-Sympathetic-Short Measurement-LF	5 Minutes	By using Holter monitorization for 24 haur. LF (frequency domain, low frequency measurement): The low-frequency (LF) spectra represents predominantly sympathetic with some parasympathetic influence in the 0.04-to-0.15 Hz range.

Secondary Outcome Measures

Name	Time	Method
Time Domain Measurements of HRV	5 Minutes	By using Holter monitorization for 24 haur, 5 different measurements get by 5 minutes heart rate analysis: SDNN, SDANN,SDNN index,Rmssd,pNN50 SDNN: ms, Standard deviation of all NN intervals. SDANN: ms Standard deviation of the averages of NN intervals in all 5 min segments of the entire recording.; SDNN index: ms, mean of the standard deviations of all NN intervals for all 5 min segments of the entire recording RMSSD: ms, The square root of the mean of the sum of the squares of diVerences between adjacent NN intervals.; pNN50: % NN50 count divided by the total number of all NN intervals

Trial Locations

Locations (1)

Fatih University School of Medicine; 🇹🇷 Ankara, Turkey