NCT01865409

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

1.3 years

First QC Date

May 27, 2013

Last Update Submit

September 7, 2014

Conditions

ImmaturityOral IntolerancePostnatal Adaptation

Keywords

NewbornPrematuresFeeding difficultyKangaroo CareHeart rate variability

Outcome Measures

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.

    5 Minutes

Secondary Outcomes (1)

  • Time Domain Measurements of HRV

    5 Minutes

Study Arms (1)

Kangoroo care

ACTIVE COMPARATOR

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

Kangaroo CareBEHAVIORAL

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
Kangoroo care

Eligibility Criteria

Age32 Weeks - 35 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih University School of Medicine

Ankara, Ankara, 06590, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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.

    PMID: 22273634BACKGROUND

  • 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.

    PMID: 8598068BACKGROUND

  • 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.

    PMID: 21543958BACKGROUND

MeSH Terms

Interventions

Kangaroo-Mother Care Method

Intervention Hierarchy (Ancestors)

Patient PositioningPatient CareTherapeuticsInfant CareChild CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mehmet Kenan Kanburoglu, MD

    Neonatologist

    STUDY DIRECTOR

  • Mehmet Nevzat Cizmeci, MD

    Neonatologist

    PRINCIPAL INVESTIGATOR

  • Mustafa Mansur Tatli, MD, Prof

    Neonatologist

    STUDY CHAIR

Central Study Contacts

Mehmet Kenan Kanburoglu, MD

CONTACT

+905326685916madduckk@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Kanburoglu, neonatologist

Study Record Dates

First Submitted

May 27, 2013

First Posted

May 30, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 9, 2014

Record last verified: 2014-09

Locations

TU(1)