Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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: The impact on breast milk volume and macronutrient content (calories, fat, proteins, and carbohydrates) Parental experience and perceptions with Kangaroo Care in the University of California (UC) Davis NICU. Parental participants will: Come to the UC Davis NICU for scheduled visits - 4 total visits in a 10 day period. Perform Kangaroo Care (holding your baby skin to skin on your chest) for one hour (nurses and other staff will help you place baby comfortably on your chest and be there to help with any questions/concerns while holding) Express breast milk per visit schedule (Either before or after Kangaroo Care) using hospital grade pump provided by the NICU Provide breast milk sample for analysis (6ml or just over a teaspoon) Participate in a brief interview over Zoom (no video required) - this will be about 20 minutes in length Healthcare provider participants will: •Participate in a brief interview over Zoom (no video required) - this will be about 20 minutes in length

Official Title
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Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care

Conditions
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Lactation Disorder With Baby Delivered, Nutrition Disorder, Infant

Intervention / Treatment
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* Behavioral: Kangaroo Care
* Behavioral: No Kangaroo Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lactating Parent/Infant Dyads: Lactating parents of infants who are currently admitted to the UCDMC NICU and are expected to remain in the NICU for at least 2 weeks from study enrollment Lactating parent is 18 years of age or older Infant with prematurity or other conditions prohibiting nutritive feeding at the breast during the study period Lactating parent plans to feed their infants breast milk for at least 1 month Lactating parent is willing to refrain from tandem feeding another child during the study period Willing to refrain from enrolling infant in an interventional research study that may impact growth or feeding tolerance during the study period Lactating parent is willing to use a hospital grade pump available in the NICU to express milk for sample collection Lactating Parent that is willing to travel to UCDMC on 4 occasions within a 10 day period for study visits Providers/staff: 1. Physicians, nurses, fellows, residents, and NICU staff involved in the implementation of Kangaroo care for the MILK study. Exclusion Criteria: Infant less than 1 week of age at enrollment Lactating parents expressing breast milk for more than one infant Lactating parents who are currently or plan to tandem feed another child during the study period Lactating parents that are participating in an interventional research study that could influence breast milk production. Lactating parents with infants deemed by primary investigator/primary care team to be too unstable for kangaroo care Lactating parents that are unwilling to participate in kangaroo care Dyads that have participated in nutritive feeding at the breast Lactating parents that use recreational drugs that contraindicate breastfeeding/provision of breast milk Lactating parents taking therapies, supplements, or medications that are incompatible with breastfeeding/provision of breast milk to their infant Lactating parents using, or planning to use, any over-the-counter or prescription medication for the purpose of increasing milk supply (including domperidone, fenugreek, turmeric, blessed milk thistle, Brewer's yeast, or lactation cookies) Lactating parents that are involuntarily confined Lactating parents that are adults unable to consent Lactating parents unwilling to travel to UC Davis NICU for study visits Anyone deemed unfit for participation by the investigator(s)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This study is a mixed methods study comprising of a randomized, crossover interventional trial of Kangaroo Care vs Control and milk expression, study of implementation of scheduled Kangaroo Care in the UC Davis NICU, and qualitative interviews of providers and parents to understand their attitudes and experiences with Kangaroo Care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Kangaroo Care Arm (KC)<br>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. | Behavioral: Kangaroo Care<br>* 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.<br>|
| Placebo Comparator: Control Arm (CON)<br>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. | Behavioral: No Kangaroo Care<br>* Lactating parents will provide a breast milk sample after having no contact with their infant for at least 6 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast milk calories (kcal/dL) by kangaroo care intervention | 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. | 10 days | 
| Breast milk fat (g/dL) by kangaroo care intervention | 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. | 10 days | 
| Breast milk protein (g/dL) by kangaroo care intervention | 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. | 10 days | 
| Breast milk carbohydrate (g/dL) by kangaroo care intervention | 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. | 10 days | 
| Breast milk volume in mL by kangaroo care intervention | 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. | 10 days | 
| Implementation of scheduled Kangaroo Care Visits in the UC Davis NICU - KC time | Record minutes spent in Kangaroo Care during each study visit | 10 days | 
| Implementation of scheduled Kangaroo Care Visits in the UC Davis NICU - KC incomplete | 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) | 10 days | 
| Implementation of scheduled Kangaroo Care Visits in the UC Davis NICU - Parental attitudes | Qualitative survey (via zoom) of parents after study visit completion to better understand attitudes and experiences with scheduled Kangaroo Care visits. | 9 months | 
| Implementation of scheduled Kangaroo Care Visits in the UC Davis NICU - Provider attitudes | Qualitative survey (via zoom) of NICU providers after participation in study visit completion to better understand attitudes and experiences with scheduled Kangaroo Care visits. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of breast milk provision | Determine the length of time that breast milk is provided to the infant during the infant's hospital stay. | 9 months | 
| Infant growth (Birth weight and discharge weight in grams) during NICU hospitalization | Examine infant growth during NICU hospitalization, recording the birth weight and discharge weight | 9 months | 
| Infant growth (Birth length and discharge length in cm) during NICU hospitalization | Examine infant growth during NICU hospitalization, recording the birth weight and discharge weight | 9 months | 
| Infant growth (Birth head circumference and discharge head circumference in cm) during NICU hospitalization | Examine infant growth during NICU hospitalization, recording the birth weight and discharge weight | 9 months | 
| Infant growth (Birth weight z-score and discharge weight z-score) during NICU hospitalization | Examine infant growth during NICU hospitalization, recording the birth weight z-score and discharge weight z-score | 9 months | 
| Infant growth (Birth length z-score and discharge length z-score) during NICU hospitalization | Examine infant growth during NICU hospitalization, recording the birth weight z-score and discharge weight z-score | 9 months | 
| Infant growth (Birth head circumference z-score and discharge head circumference z-score) during NICU hospitalization | Examine infant growth during NICU hospitalization, recording the birth weight z-score and discharge weight z-score | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lactation, Kangaroo Care, NICU, Breast milk, Nutrition, Skin to skin