Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care

Nutrition Disorder, Infant Clinical Trial

— MILK  

Official title:

Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06047470
• Other study ID #: 1982835
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: October 2024

Study information

• Verified date: September 2023
• Source: University of California, Davis
• Contact: Kara Kuhn-Riordon, MD
• Phone: 916-703-3050
• Email: kmkuhn[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: October 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

Lactating Parent/Infant Dyads:

1. 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

2. Lactating parent is 18 years of age or older

3. Infant with prematurity or other conditions prohibiting nutritive feeding at the breast during the study period

4. Lactating parent plans to feed their infants breast milk for at least 1 month

5. Lactating parent is willing to refrain from tandem feeding another child during the study period

6. Willing to refrain from enrolling infant in an interventional research study that may impact growth or feeding tolerance during the study period

7. Lactating parent is willing to use a hospital grade pump available in the NICU to express milk for sample collection

8. 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:

1. Infant less than 1 week of age at enrollment

2. Lactating parents expressing breast milk for more than one infant

3. Lactating parents who are currently or plan to tandem feed another child during the study period

4. Lactating parents that are participating in an interventional research study that could influence breast milk production.

5. Lactating parents with infants deemed by primary investigator/primary care team to be too unstable for kangaroo care

6. Lactating parents that are unwilling to participate in kangaroo care

7. Dyads that have participated in nutritive feeding at the breast

8. Lactating parents that use recreational drugs that contraindicate breastfeeding/provision of breast milk

9. Lactating parents taking therapies, supplements, or medications that are incompatible with breastfeeding/provision of breast milk to their infant

10. 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)

11. Lactating parents that are involuntarily confined

12. Lactating parents that are adults unable to consent

13. Lactating parents unwilling to travel to UC Davis NICU for study visits

14. Anyone deemed unfit for participation by the investigator(s)

Related Conditions & MeSH terms

• Infant Nutrition Disorders
• Lactation Disorders
• Nutrition Disorder, Infant
• Nutrition Disorders

Intervention

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

Locations

Country	Name	City	State
United States	UC Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (18)

Acuna-Muga J, Ureta-Velasco N, de la Cruz-Bertolo J, Ballesteros-Lopez R, Sanchez-Martinez R, Miranda-Casabona E, Miguel-Trigoso A, Garcia-San Jose L, Pallas-Alonso C. Volume of milk obtained in relation to location and circumstances of expression in mothers of very low birth weight infants. J Hum Lact. 2014 Feb;30(1):41-6. doi: 10.1177/0890334413509140. Epub 2013 Nov 8. — View Citation

Coskun D, Gunay U. The Effects of Kangaroo Care Applied by Turkish Mothers who Have Premature Babies and Cannot Breastfeed on Their Stress Levels and Amount of Milk Production. J Pediatr Nurs. 2020 Jan-Feb;50:e26-e32. doi: 10.1016/j.pedn.2019.09.028. Epub 2019 Oct 28. — View Citation

Furman L, Taylor G, Minich N, Hack M. The effect of maternal milk on neonatal morbidity of very low-birth-weight infants. Arch Pediatr Adolesc Med. 2003 Jan;157(1):66-71. doi: 10.1001/archpedi.157.1.66. — View Citation

Health WHOR, Organization WH, UNAIDS. Kangaroo Mother Care: A Practical Guide. World Health Organization; 2003.

Hill PD, Aldag JC, Chatterton RT. Effects of pumping style on milk production in mothers of non-nursing preterm infants. J Hum Lact. 1999 Sep;15(3):209-16. doi: 10.1177/089033449901500310. — View Citation

Hill PD, Aldag JC. Milk volume on day 4 and income predictive of lactation adequacy at 6 weeks of mothers of nonnursing preterm infants. J Perinat Neonatal Nurs. 2005 Jul-Sep;19(3):273-82. doi: 10.1097/00005237-200507000-00014. — View Citation

Kumar RK, Singhal A, Vaidya U, Banerjee S, Anwar F, Rao S. Optimizing Nutrition in Preterm Low Birth Weight Infants-Consensus Summary. Front Nutr. 2017 May 26;4:20. doi: 10.3389/fnut.2017.00020. eCollection 2017. — View Citation

Lau C, Hurst NM, Smith EO, Schanler RJ. Ethnic/racial diversity, maternal stress, lactation and very low birthweight infants. J Perinatol. 2007 Jul;27(7):399-408. doi: 10.1038/sj.jp.7211770. — View Citation

Lucas A, Cole TJ. Breast milk and neonatal necrotising enterocolitis. Lancet. 1990 Dec 22-29;336(8730):1519-23. doi: 10.1016/0140-6736(90)93304-8. — View Citation

Martin CR, Ling PR, Blackburn GL. Review of Infant Feeding: Key Features of Breast Milk and Infant Formula. Nutrients. 2016 May 11;8(5):279. doi: 10.3390/nu8050279. — View Citation

Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52. — View Citation

Mimouni FB, Lubetzky R, Yochpaz S, Mandel D. Preterm Human Milk Macronutrient and Energy Composition: A Systematic Review and Meta-Analysis. Clin Perinatol. 2017 Mar;44(1):165-172. doi: 10.1016/j.clp.2016.11.010. — View Citation

Parker LA, Sullivan S, Krueger C, Kelechi T, Mueller M. Strategies to increase milk volume in mothers of VLBW infants. MCN Am J Matern Child Nurs. 2013 Nov-Dec;38(6):385-90. doi: 10.1097/NMC.0b013e3182a1fc2f. — View Citation

Schanler RJ, Shulman RJ, Lau C. Feeding strategies for premature infants: beneficial outcomes of feeding fortified human milk versus preterm formula. Pediatrics. 1999 Jun;103(6 Pt 1):1150-7. doi: 10.1542/peds.103.6.1150. — View Citation

Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27. — View Citation

Sisk PM, Lovelady CA, Dillard RG, Gruber KJ, O'Shea TM. Early human milk feeding is associated with a lower risk of necrotizing enterocolitis in very low birth weight infants. J Perinatol. 2007 Jul;27(7):428-33. doi: 10.1038/sj.jp.7211758. Epub 2007 Apr 19. Erratum In: J Perinatol. 2007 Dec;27(12):808. — View Citation

Vohr BR, Poindexter BB, Dusick AM, McKinley LT, Higgins RD, Langer JC, Poole WK; National Institute of Child Health and Human Development National Research Network. Persistent beneficial effects of breast milk ingested in the neonatal intensive care unit on outcomes of extremely low birth weight infants at 30 months of age. Pediatrics. 2007 Oct;120(4):e953-9. doi: 10.1542/peds.2006-3227. — View Citation

Vohr BR, Poindexter BB, Dusick AM, McKinley LT, Wright LL, Langer JC, Poole WK; NICHD Neonatal Research Network. Beneficial effects of breast milk in the neonatal intensive care unit on the developmental outcome of extremely low birth weight infants at 18 months of age. Pediatrics. 2006 Jul;118(1):e115-23. doi: 10.1542/peds.2005-2382. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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