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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
Sponsor:
Information provided by (Responsible Party):
Mehmet Kenan Kanburoglu, 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.

Condition or disease Intervention/treatment Phase
Immaturity Oral Intolerance Postnatal Adaptation Behavioral: Kangaroo Care Not Applicable

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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

Arm Intervention/treatment
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.
Other Names:
  • Kangaroo Mother Care
  • Skin to skin contact




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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




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Ages Eligible for Study:   32 Weeks to 35 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Mehmet Kenan Kanburoglu, MD +905326685916 madduckk@gmail.com

Locations
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Turkey
Fatih University School of Medicine Recruiting
Ankara, Turkey, 06590
Contact: Mehmet Kenan Kanburoglu, MD    +905326685916    madduckk@gmail.com   
Sponsors and Collaborators
Fatih University
Investigators
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Study Director: Mehmet Kenan Kanburoglu, MD Neonatologist
Principal Investigator: Mehmet Nevzat Cizmeci, MD Neonatologist
Study Chair: Mustafa Mansur Tatli, MD, Prof Neonatologist