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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02919540
Other study ID # 26/94/2016
Secondary ID
Status Completed
Phase N/A
First received September 27, 2016
Last updated April 10, 2018
Start date September 2016
Est. completion date February 24, 2018

Study information

Verified date April 2018
Source Jordan University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date February 24, 2018
Est. primary completion date February 24, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Kangaroo care approach
skin to skin contact between stable preterm infants and their naked mother's chest

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Jordan University of Science and Technology

Outcome

Type Measure Description Time frame Safety issue
Primary Breastfeeding outcome Breastfeeding outcome will be measured for both groups by the numbers of preterm infants discharged on either exclusive or partial breastfeeding 4-6 months
Secondary Body temperature Axillary body temperature will be measured using an electronic thermometer 4-6 months
Secondary Heart rate (beat per minute) Continuous electrocardiogram (ECG) data will be recorded from two surface chest electrodes 4-6 months
Secondary 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 4-6 months
See also
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Recruiting NCT02048202 - Medical Clowning in the NICU (Neonatal Intensive Care Unit and Their Effects on Parents and Staff N/A
Completed NCT02799875 - Late Permissive Hypercapnia for Intubated and Ventilated Preterm Infants N/A