Effect of Kangaroo Care on Heart Rate Variability

Study Overview
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Brief Summary
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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.

Official Title
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Does Kangaroo Care Effects on Heart Rate Variability in Neonates

Conditions
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Immaturity, Oral Intolerance, Postnatal Adaptation

Intervention / Treatment
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* Behavioral: Kangaroo Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 32 Weeks
Maximum Age: 35 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Kangoroo care<br>While performing Kangaroo care the infant should be held skin-to-skin contact with her mother for 30-60 minutes. The baby, who is naked except for a diaper and a piece of cloth covering his or her back (either a receiving blanket or the parent's clothing), is placed in an upright position against a parent's bare chest. The values of heart rate variability will be measured during and also without Kangaroo Care in the same infants but different times. | Behavioral: Kangaroo Care<br>* Kangaroo care is a technique practiced on newborn, usually preterm, infants wherein the infant is held, skin-to-skin, with an adult.<br>* Other names: Skin to skin contact;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HRV-Sympathetic-Short Measurement-LF | 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. | 5 Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Domain Measurements of HRV | 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 | 5 Minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Newborn, Prematures, Feeding difficulty, Kangaroo Care, Heart rate variability