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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 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kangaroo Care Arm (KC) | Active Comparator | 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. |
|
| Control Arm (CON) | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kangaroo Care | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Lactating Parent/Infant Dyads:
Providers/staff:
1. Physicians, nurses, fellows, residents, and NICU staff involved in the implementation of Kangaroo care for the MILK study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kara Kuhn-Riordon, MD | UC Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22371471 | Background | 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. | |
| 1979363 | Background | 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. |
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| ID | Term |
|---|---|
| D007228 | Infant Nutrition Disorders |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D060127 | Kangaroo-Mother Care Method |
| ID | Term |
|---|---|
| D056888 | Patient Positioning |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D007224 | Infant Care |
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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.
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| No Kangaroo Care | Behavioral | Lactating parents will provide a breast milk sample after having no contact with their infant for at least 6 hours. |
|
| 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 |
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 |
| 17443195 | Background | 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. |
| 10353922 | Background | 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. |
| 12517197 | Background | 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. |
| 17908750 | Background | 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. |
| 16818526 | Background | 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. |
| 28603716 | Background | 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. |
| 27187450 | Background | 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. |
| 28159203 | Background | 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. |
| 24212300 | Background | 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. |
| 8506163 | Background | Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52. |
| Background | Health WHOR, Organization WH, UNAIDS. Kangaroo Mother Care: A Practical Guide. World Health Organization; 2003. |
| 16106236 | Background | 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. |
| 10578798 | Background | 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. |
| 17592486 | Background | 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. |
| 24145494 | Background | 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. |
| 31672261 | Background | 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. |
| D002654 |
| Child Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |