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

About this trial
This is an interventional supportive care trial for Premature Neonate
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.
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
NCT ID
NCT02919540
First Posted
September 27, 2016
Last Updated
April 10, 2018
Sponsor
Jordan University of Science and Technology
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
Learn more about this trial
Effect of "Kangaroo Mother Care" on Premature Infants Physiological Outcomes
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