MILK: Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care

Sponsor

University of California, Davis (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06047470

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lactation Disorder With Baby Delivered Nutrition Disorder, Infant	Behavioral: Kangaroo Care Behavioral: No Kangaroo Care	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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)

Primary Purpose:

Health Services Research

Official Title:

Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Kangaroo Care Arm (KC) 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 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.
Placebo Comparator: Control Arm (CON) 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 Lactating parents will provide a breast milk sample after having no contact with their infant for at least 6 hours.

Arm

Intervention/Treatment

Active Comparator: Kangaroo Care Arm (KC)

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

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.

Placebo Comparator: Control Arm (CON)

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

Lactating parents will provide a breast milk sample after having no contact with their infant for at least 6 hours.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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:

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)