Effect of Kangaroo Care on Heart Rate Variability

NCT ID: NCT01865409

Last Updated: 2014-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-09-30

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.

Detailed Description

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Conditions

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Immaturity Oral Intolerance Postnatal Adaptation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Kangaroo Care

Intervention Type BEHAVIORAL

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

Interventions

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Kangaroo Care

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Kangaroo Mother Care Skin to skin contact

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
Minimum Eligible Age

32 Weeks

Maximum Eligible Age

35 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fatih University

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Kenan Kanburoglu

MD Kanburoglu, neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehmet Kenan Kanburoglu, MD

Role: STUDY_DIRECTOR

Neonatologist

Mehmet Nevzat Cizmeci, MD

Role: PRINCIPAL_INVESTIGATOR

Neonatologist

Mustafa Mansur Tatli, MD, Prof

Role: STUDY_CHAIR

Neonatologist

Locations

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Fatih University School of Medicine

Ankara, Ankara, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Mehmet Kenan Kanburoglu, MD

Role: CONTACT

+905326685916

Facility Contacts

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Mehmet Kenan Kanburoglu, MD

Role: primary

+905326685916

References

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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.

Reference Type BACKGROUND
PMID: 22273634 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8598068 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21543958 (View on PubMed)

Other Identifiers

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B 30 FTH 0 20 00 00 / 1503

Identifier Type: -

Identifier Source: org_study_id

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