Effect of Kangaroo Care on Heart Rate Variability
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|ClinicalTrials.gov Identifier: NCT01865409|
Recruitment Status : Unknown
Verified September 2014 by Mehmet Kenan Kanburoglu, Fatih University.
Recruitment status was: Recruiting
First Posted : May 30, 2013
Last Update Posted : September 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Immaturity Oral Intolerance Postnatal Adaptation||Behavioral: Kangaroo Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Does Kangaroo Care Effects on Heart Rate Variability in Neonates|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||September 2014|
Active Comparator: Kangoroo care
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
Kangaroo care is a technique practiced on newborn, usually preterm, infants wherein the infant is held, skin-to-skin, with an adult.
- HRV-Sympathetic-Short Measurement-LF [ Time Frame: 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.
- Time Domain Measurements of HRV [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865409
|Contact: Mehmet Kenan Kanburoglu, MDfirstname.lastname@example.org|
|Fatih University School of Medicine||Recruiting|
|Ankara, Turkey, 06590|
|Contact: Mehmet Kenan Kanburoglu, MD +905326685916 email@example.com|
|Study Director:||Mehmet Kenan Kanburoglu, MD||Neonatologist|
|Principal Investigator:||Mehmet Nevzat Cizmeci, MD||Neonatologist|
|Study Chair:||Mustafa Mansur Tatli, MD, Prof||Neonatologist|