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Completed

NCT Number: NCT02919540

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

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.

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Key information

Conditions

Premature Neonate Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kangaroo care approach

Other

skin to skin contact between stable preterm infants and their naked mother's chest

Primary outcomes

  1. Breastfeeding outcome

    Time frame: 4-6 months

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

Secondary outcomes

  1. Body temperature

    Time frame: 4-6 months

    Axillary body temperature will be measured using an electronic thermometer

  2. Heart rate (beat per minute)

    Time frame: 4-6 months

    Continuous electrocardiogram (ECG) data will be recorded from two surface chest electrodes

  3. Respiratory activity (breath per minute)

    Time frame: 4-6 months

    A non-invasive signal monitor connected to the infant cardio-respiratory monitor that captures ECG and respiratory data will be used

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

Effect of "Kangaroo Mother Care Approach" on Premature Infants' Physiological Outcomes in Jordan

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 29, 2016
Registry last updated
Apr 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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