CClinicalTrials.gg
Status unknownNCT01865409Updated Sep 9, 2014

Effect of Kangaroo Care on Heart Rate Variability

An interventional study of Kangaroo Care in Immaturity, Oral Intolerance and Postnatal Adaptation, sponsored by Fatih University. Status unknown at 1 site in Turkey. Open to participants aged 32 Weeks to 35 Weeks. Per ClinicalTrials.gov, last updated 2014-09-09.

Sponsored by Fatih University · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Sep 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
32 Weeks to 35 Weeks
Sex
All
01

Study 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.

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Conditions studied

  • Immaturity
  • Oral Intolerance
  • Postnatal Adaptation

Keywords

  • Newborn
  • Prematures
  • Feeding difficulty
  • Kangaroo Care
  • Heart rate variability
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In context

Lead sponsor

Fatih University is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
32 Weeks to 35 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

Interventions

  • BehavioralKangaroo Care

    Kangaroo care is a technique practiced on newborn, usually preterm, infants wherein the infant is held, skin-to-skin, with an adult.

    Also known as: Kangaroo Mother Care, Skin to skin contact

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 Minutes

Secondary outcomes

  1. 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

    Time frame: 5 Minutes

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Study locations

1 of 1 sites recruiting
  • Fatih University School of Medicine
    Ankara, 06590, Turkey
    Recruiting
08

References and documents

Publications

  • Srinivasan L, Harris MC. New technologies for the rapid diagnosis of neonatal sepsis. Curr Opin Pediatr. 2012 Apr;24(2):165-71. doi: 10.1097/MOP.0b013e3283504df3. PubMed 22273634 ↗
  • Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available. PubMed 8598068 ↗
  • Harrison TM. Trajectories of parasympathetic nervous system function before, during, and after feeding in infants with transposition of the great arteries. Nurs Res. 2011 May-Jun;60(3 Suppl):S15-27. doi: 10.1097/NNR.0b013e31821600b1. PubMed 21543958 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01865409
Lead sponsor
Fatih University
Responsible party
Mehmet Kenan Kanburoglu (MD Kanburoglu, neonatologist, Fatih University) — Principal investigator
First posted
May 30, 2013
Start date
Jun 2013
Primary completion
Sep 2014 (estimated)
Completion
Sep 2014 (estimated)
Last update
Sep 9, 2014

Study contacts

Mehmet Kenan Kanburoglu, MD
Contact
madduckk@gmail.com
+905326685916
Mehmet Kenan Kanburoglu, MD
study director · Neonatologist
Mehmet Nevzat Cizmeci, MD
principal investigator · Neonatologist
Mustafa Mansur Tatli, MD, Prof
study chair · Neonatologist

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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