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Effect of "Kangaroo Mother Care" on Premature Infants Physiological Outcomes

Primary Purpose

Premature Neonate

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Kangaroo care approach
Sponsored by
Jordan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature Neonate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • all stable preterm or low birth weight infants (stable infants are those who are able to breath unassisted and have no major health problems (WHO, 2003)), weighing more than 1800gm, who are admitted to the NICUs at the time of study and whose mothers consent to participate and willing to practice the KMC with her infant

Exclusion Criteria:

  • high risk preterm or low birth weight infants.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    kangaroo care approach

    control group

    Arm Description

    the kangaroo care approach will be implemented for dyads who agree to participate

    routine care will be implemented

    Outcomes

    Primary Outcome Measures

    Breastfeeding outcome
    Breastfeeding outcome will be measured for both groups by the numbers of preterm infants discharged on either exclusive or partial breastfeeding

    Secondary Outcome Measures

    Body temperature
    Axillary body temperature will be measured using an electronic thermometer
    Heart rate (beat per minute)
    Continuous electrocardiogram (ECG) data will be recorded from two surface chest electrodes
    Respiratory activity (breath per minute)
    A non-invasive signal monitor connected to the infant cardio-respiratory monitor that captures ECG and respiratory data will be used

    Full Information

    First Posted
    September 27, 2016
    Last Updated
    April 10, 2018
    Sponsor
    Jordan University of Science and Technology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02919540
    Brief Title
    Effect of "Kangaroo Mother Care" on Premature Infants Physiological Outcomes
    Official Title
    Effect of "Kangaroo Mother Care Approach" on Premature Infants' Physiological Outcomes in Jordan
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2016 (Actual)
    Primary Completion Date
    February 24, 2018 (Actual)
    Study Completion Date
    February 24, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jordan University of Science and Technology

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This project aims at testing the effect of applying the KMC on the premature infants' physiological outcomes. The findings of this project are expected to contribute to the discipline of preterm infants' care by providing evidence of the benefits, barriers, and facilities of providing the KMC in our Jordanian NICUs.
    Detailed Description
    Premature infants are often unable physiologically to adapt well to the stressful environment of the NICU. These neonates are commonly at risk for the development of short and long term outcomes ranging from mild developmental delay to severe disability. The Kangaroo mother care approach (KMC) is developed to minimize the effect of prematurity and the NICU environmental stressors on premature infants. This project aims at assessing the neonatal nurses' knowledge and attitudes of the application of the KMC approach in the neonatal intensive care unit (NICU), testing the effect of applying the KMC on the premature infants' physiological outcomes, and exploring the mothers' lived experiences of providing KMC for their premature infants. The findings of this project are expected to contribute to the discipline of preterm infants' care by providing evidence of the benefits, barriers, and facilities of providing the KMC in our Jordanian NICUs.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature Neonate

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    kangaroo care approach
    Arm Type
    Experimental
    Arm Description
    the kangaroo care approach will be implemented for dyads who agree to participate
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    routine care will be implemented
    Intervention Type
    Other
    Intervention Name(s)
    Kangaroo care approach
    Intervention Description
    skin to skin contact between stable preterm infants and their naked mother's chest
    Primary Outcome Measure Information:
    Title
    Breastfeeding outcome
    Description
    Breastfeeding outcome will be measured for both groups by the numbers of preterm infants discharged on either exclusive or partial breastfeeding
    Time Frame
    4-6 months
    Secondary Outcome Measure Information:
    Title
    Body temperature
    Description
    Axillary body temperature will be measured using an electronic thermometer
    Time Frame
    4-6 months
    Title
    Heart rate (beat per minute)
    Description
    Continuous electrocardiogram (ECG) data will be recorded from two surface chest electrodes
    Time Frame
    4-6 months
    Title
    Respiratory activity (breath per minute)
    Description
    A non-invasive signal monitor connected to the infant cardio-respiratory monitor that captures ECG and respiratory data will be used
    Time Frame
    4-6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: all stable preterm or low birth weight infants (stable infants are those who are able to breath unassisted and have no major health problems (WHO, 2003)), weighing more than 1800gm, who are admitted to the NICUs at the time of study and whose mothers consent to participate and willing to practice the KMC with her infant Exclusion Criteria: high risk preterm or low birth weight infants.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    khulood K. Shattnawi, PhD
    Organizational Affiliation
    Jordan University of Science and Technology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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