UC Davis
Sacramento, California, 95817, United States
NCT Number: NCT06047470
The goal of this clinical trial is to learn about the impact of Kangaroo Care (holding your baby skin-to-skin on your chest) in lactating parents with babies in the Neonatal Intensive Care Unit (NICU) that cannot directly breastfeed.
This study is active but is not currently recruiting participants.
Notify Me18 year–100 year
Female
Interventional
Not applicable
Sacramento, California, 95817, United States
The goal of this clinical trial is to learn about the impact of Kangaroo Care (holding your baby skin-to-skin on your chest) in lactating parents with babies in the Neonatal Intensive Care Unit (NICU) that cannot directly breastfeed.
The main questions it aims to answer are:
Parental participants will:
Healthcare provider participants will:
•Participate in a brief interview over Zoom (no video required) - this will be about 20 minutes in length
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Lactating Parent/Infant Dyads:
Providers/staff:
Exclusion criteria
Lactating parents will participate in kangaroo care (holding an infant upright, directly on the chest with skin-to-skin contact) prior to expressing a breast milk sample.
Lactating parents will provide a breast milk sample after having no contact with their infant for at least 6 hours.
Time frame: 10 days
The difference in expressed breast milk caloric composition/energy content) between samples collected after participating in kangaroo care and those collected after having no contact with the infant for at least 6 hours.
Time frame: 10 days
The difference in expressed breast milk fat content between samples collected after participating in kangaroo care and those collected after having no contact with the infant for at least 6 hours.
Time frame: 10 days
The difference in expressed breast milk protein content between samples collected after participating in kangaroo care and those collected after having no contact with the infant for at least 6 hours.
Time frame: 10 days
The difference in expressed breast milk carbohydrate content between samples collected after participating in kangaroo care and those collected after having no contact with the infant for at least 6 hours.
Time frame: 10 days
The difference in expressed breast milk volume expression between samples collected after participating in kangaroo care and after having no contact with the infant for at least 6 hours.
Time frame: 10 days
Record minutes spent in Kangaroo Care during each study visit
Time frame: 10 days
Record reasons for KC visits lasting less than 60 minutes - including infant causes (clinical instability, intolerance, technical issues with equipment) and parental causes (parental discomfort/anxiety, parental scheduling conflict, need to use restroom/express breast milk)
Time frame: 9 months
Qualitative survey (via zoom) of parents after study visit completion to better understand attitudes and experiences with scheduled Kangaroo Care visits.
Time frame: 9 months
Qualitative survey (via zoom) of NICU providers after participation in study visit completion to better understand attitudes and experiences with scheduled Kangaroo Care visits.
Time frame: 9 months
Determine the length of time that breast milk is provided to the infant during the infant's hospital stay.
Time frame: 9 months
Examine infant growth during NICU hospitalization, recording the birth weight and discharge weight
Time frame: 9 months
Examine infant growth during NICU hospitalization, recording the birth weight and discharge weight
Time frame: 9 months
Examine infant growth during NICU hospitalization, recording the birth weight and discharge weight
Time frame: 9 months
Examine infant growth during NICU hospitalization, recording the birth weight z-score and discharge weight z-score
Time frame: 9 months
Examine infant growth during NICU hospitalization, recording the birth weight z-score and discharge weight z-score
Time frame: 9 months
Examine infant growth during NICU hospitalization, recording the birth weight z-score and discharge weight z-score
University of California, Davis
Other
Acronym: MILK
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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