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Behavioral Intervention
Kangaroo Care for Lactation Disorders (MILK Trial)
N/A
Recruiting
Led By Kara Kuhn-Riordon, MD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Infant with prematurity or other conditions prohibiting nutritive feeding at the breast during the study period
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
MILK Trial Summary
This trial will study how Kangaroo Care helps NICU babies and their families, who can't breastfeed. #kangaroocare #NICU
Who is the study for?
This trial is for lactating parents with infants in the NICU who plan to provide breast milk for at least a month, can use a hospital pump, and are willing to visit UC Davis NICU four times in ten days. It's not for those feeding multiple infants, using certain drugs or supplements, or whose babies are too unstable for kangaroo care.Check my eligibility
What is being tested?
The study examines the effects of Kangaroo Care (skin-to-skin contact) on lactating parents' ability to provide breast milk when their baby cannot directly breastfeed due to being in the NICU.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like holding your baby close (Kangaroo Care), there aren't typical medication side effects; however, it may impact comfort levels or emotional state.
MILK Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My infant cannot be breastfed due to prematurity or other conditions.
MILK Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Breast milk calories (kcal/dL) by kangaroo care intervention
Breast milk carbohydrate (g/dL) by kangaroo care intervention
Breast milk fat (g/dL) by kangaroo care intervention
+6 moreSecondary outcome measures
Duration of breast milk provision
Infant growth (Birth head circumference and discharge head circumference in cm) during NICU hospitalization
Infant growth (Birth head circumference z-score and discharge head circumference z-score) during NICU hospitalization
+4 moreMILK Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Kangaroo Care Arm (KC)Active Control1 Intervention
Lactating parents will be asked to arrive at the NICU 2 hours after they have fully expressed their breasts at home and to provide their infants with kangaroo care for 1 hour. Following KC and while still at the infant's bedside, lactating parents will be asked to pump from both of their breasts using a hospital grade pump available in the NICU. Study personnel will weigh the collected milk to determine the total volume of milk expressed by mass. The milk collected from both breasts will be gently swirled six times or more until the fat layer is incorporated in the bottle and will be combined into one bottle. Study personnel will take one 6 mL aliquot from the collected milk for compositional analysis. The remainder of the milk will be saved in the NICU per routine so that it can be fed to the infant later.
Group II: Control Arm (CON)Placebo Group1 Intervention
Lactating parents will be asked to arrive at the NICU 3 hours after they have fully expressed their breasts at home. Lactating parents will be taken to a private room where they will be asked to pump from both of their breasts using a hospital grade pump available in the NICU. Study personnel will weigh the collected milk to determine the total volume of milk expressed by mass. The milk collected from both breasts will be gently swirled six times or more until the fat layer is incorporated in the bottle and will be combined into one bottle. Study personnel will take one 6 mL aliquot from the collected milk for compositional analysis. The remainder of the milk will be saved in the NICU per routine so that it can be fed to the infant later. Lactating parents will then provide their infants with kangaroo care for 1 hour.
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Who is running the clinical trial?
University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,494 Total Patients Enrolled
Kara Kuhn-Riordon, MDPrincipal InvestigatorUC Davis
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an ongoing recruitment initiative for participants in this trial?
"According to clinicaltrials.gov, recruitment for this particular trial has been terminated as of September 14th 2023. Initially posted on October 1st 20203, the study is no longer accepting participants; however there are still 34 other studies that are open for enrollment."
Answered by AI
What objectives are being pursued through this scientific investigation?
"The primary metric of this 10-day trial is measuring the fat content (g/dL) in breast milk with kangaroo care intervention, while secondary outcomes include evaluating infant growth during their NICU hospitalization via recording birth weight, length and head circumference measurements at discharge."
Answered by AI
Is the age requirement for this research restricted to persons below 40?
"According to the trial's requirements, participants must be between 18 and 100 years of age."
Answered by AI
What qualifications are necessary for individuals to become participants in this trial?
"To qualify for this clinical research, candidates must be afflicted with a nutritional disorder and fit within the 18-100 age range. The team responsible for conducting the study is in need of 25 volunteers."
Answered by AI
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