Lactation Disorder With Baby DeliveredMILKNCT06047470
Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care
A study testing Kangaroo Care and No Kangaroo Care in people with Lactation Disorder With Baby Delivered and Nutrition Disorder, Infant, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation Disorder With Baby Delivered, Nutrition Disorder, Infant
- What is being tested?
- Kangaroo Care and No Kangaroo Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2023to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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
- Being tested
- Kangaroo Care, No Kangaroo Care
- Keywords
- Lactation, Kangaroo Care, NICU, Breast milk, Nutrition, Skin to skin
- Medical subject headings
- Infant Nutrition Disorders, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo CareBehavioural
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 CareBehavioural
Lactating parents will provide a breast milk sample after having no contact with their infant for at least 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Kangaroo Care |
| 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. Receives: Behavioral: No Kangaroo Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 9 months
Secondary outcomes (7)
Duration of breast milk provision
Determine the length of time that breast milk is provided to the infant during the infant's hospital stay.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start15 Nov 2023
- Primary completion26 May 2025
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Lactation Disorder With Baby DeliveredStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kara Kuhn-Riordon, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047470
- Sponsor's protocol ID
- 1982835
- Acronym
- MILK
- Status last verified
- Apr 2026
- First submitted
- 1 Aug 2023
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22371471Lucas 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.
PubMed 1979363Sisk 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.
PubMed 17443195Schanler 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.
PubMed 10353922Furman 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.
PubMed 12517197Vohr 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.
PubMed 17908750Vohr 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.
PubMed 16818526Kumar 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.
PubMed 28603716Martin 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.
PubMed 27187450Mimouni 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.
PubMed 28159203Acuna-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.
PubMed 24212300Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.
PubMed 8506163Health WHOR, Organization WH, UNAIDS. Kangaroo Mother Care: A Practical Guide. World Health Organization; 2003.
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.
PubMed 16106236Hill 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.
PubMed 10578798
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care
- ClinicalTrials.gov ID
- NCT06047470
- Acronym / sponsor ID
- MILK / 1982835
- Keywords
- Lactation, Kangaroo Care, NICU, Breast milk, Nutrition, Skin to skin
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 26 May 2025 (actual)
- Study completion
- Mar 2027 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Kangaroo Care Arm (KC) | Active comparator | Behavioral: Kangaroo CareLactating 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 | Behavioral: No Kangaroo CareLactating 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kangaroo CareLactating 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. | Behavioural | Kangaroo Care Arm (KC) |
| No Kangaroo CareLactating parents will provide a breast milk sample after having no contact with their infant for at least 6 hours. | Behavioural | Control Arm (CON) |
Primary outcome
Breast milk calories (kcal/dL) by kangaroo care intervention
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Duration of breast milk provision
Time frame: 9 months
Infant growth (Birth weight and discharge weight in grams) during NICU hospitalization
Time frame: 9 months
Infant growth (Birth length and discharge length in cm) during NICU hospitalization
Time frame: 9 months
Infant growth (Birth head circumference and discharge head circumference in cm) during NICU hospitalization
Time frame: 9 months
Infant growth (Birth weight z-score and discharge weight z-score) during NICU hospitalization
Time frame: 9 months
Infant growth (Birth length z-score and discharge length z-score) during NICU hospitalization
Time frame: 9 months
Infant growth (Birth head circumference z-score and discharge head circumference z-score) during NICU hospitalization
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Background: PubMed 22371471Section 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.
- Background: PubMed 1979363Lucas 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.
- Background: PubMed 17443195Sisk 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.
- Background: PubMed 10353922Schanler 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.
- Background: PubMed 12517197Furman 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.
- Background: PubMed 17908750Vohr 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.
- Background: PubMed 16818526Vohr 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.
- Background: PubMed 28603716Kumar 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.
- Background: PubMed 27187450Martin 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.
- Background: PubMed 28159203Mimouni 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.
- Background: PubMed 24212300Acuna-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.
- Background: PubMed 8506163Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kara Kuhn-Riordon, MD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kangaroo Care and No Kangaroo Care in people with Lactation Disorder With Baby Delivered and Nutrition Disorder, Infant, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast milk calories (kcal/dL) by kangaroo care intervention (time frame: 10 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06047470, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.