Kangaroo Care for Premature Birth

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Unable to consent, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help mothers perform Kangaroo Care at home for babies born prematurely or with low birth weight in rural India. Kangaroo Care involves holding the baby skin-to-skin, which can enhance bonding and health. The study tests various combinations of support and guidance to determine the most effective approach. Mothers living near Shree Krishna Hospital, with a low birth weight baby, and who speak Gujarati may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity for mothers to contribute to research that could improve care practices for vulnerable infants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that Kangaroo Care is safe for preterm or low birth weight infants?

Research has shown that Kangaroo Care, which involves holding preterm or low birth weight babies skin-to-skin, is generally safe. Studies have found that it can significantly lower the risk of death in these infants. Specifically, a Cochrane review discovered that Kangaroo Care reduced the risk of death in low birth weight babies compared to traditional care.

This method is also associated with positive outcomes, such as better oxygen levels, improved body temperature control, and enhanced brain development. These findings suggest that Kangaroo Care is well-tolerated and beneficial for newborns, making it a promising choice for families with preterm or low birth weight babies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Kangaroo Care is unique because it emphasizes skin-to-skin contact between parents and their premature babies, which is a shift from the more conventional incubator-based care. Unlike standard treatments that might rely heavily on medical devices, Kangaroo Care aims to enhance bonding and parental involvement, which can improve both physical and emotional outcomes for the baby. Researchers are excited about this approach because it could lead to better temperature regulation, enhanced breastfeeding, and overall improved development in premature infants, all in a more natural and nurturing way.

What evidence suggests that Kangaroo Care is effective for premature birth?

Research has shown that Kangaroo Care, or skin-to-skin contact, greatly benefits premature and low birth weight babies. Studies indicate it can reduce newborn deaths by over 30% and lower the risk of dangerously low body temperature by nearly 70%. This care also aids in the development of better brain and movement skills. Babies receiving Kangaroo Care often grow better, have higher oxygen levels, and maintain stable body temperatures. Overall, Kangaroo Care provides significant health benefits for these vulnerable infants. ^{5 6 7 8 9}

Who Is on the Research Team?

Nisha Fahey, DO, MSc

Principal Investigator

University of Massachusetts Chan Medical School

Are You a Good Fit for This Trial?

This trial is for mothers in rural India with preterm or low birthweight infants who have been discharged from the Neonatal Intensive Care Unit. Specific eligibility criteria are not provided.

Inclusion Criteria

I am a healthcare provider for newborns near Shree Krishna Hospital and speak Gujarati.

Mothers of an infant born with low birthweight who is hospitalized in the NICU at Shree Krishna Hospital with an anticipated discharge weight of less than 2500g, reside in a village 'adopted' by and within a 50-kilometer radius of Shree Krishna Hospital, plan to live there for at least 6 weeks after NICU discharge, speak Gujarati, and are at least 18 years old

Mothers of former low birthweight infants who were hospitalized in the Shree Krishna Hospital NICU and performed Kangaroo Care during their infant's hospitalization, live in a village within a 50-kilometer radius of Shree Krishna Hospital, are at least 18 years old, and speak Gujarati

Exclusion Criteria

I am unable to understand or sign the consent form.

Prisoners

Pregnant women (not intentionally recruiting pregnant women)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Refinement of candidate interventions to overcome barriers to community-based Kangaroo Care

Not specified

Pilot Testing

Pilot individual candidate interventions to assess implementation outcomes

6 weeks

Optimization Trial

Conduct a MOST design-based optimization trial to develop a community-informed, multicomponent intervention

6 weeks

Follow-up

Participants are monitored for uptake and adherence to community-based Kangaroo Care

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Kangaroo Care

Trial Overview The study focuses on behavioral interventions to promote Kangaroo Care, which involves skin-to-skin contact between mother and infant to support the baby's development.

How Is the Trial Designed?

Group I: Base Intervention + Behavioral Interventions B + C Experimental Treatment 1 Intervention

Group II: Base Intervention + Behavioral Interventions A + C Experimental Treatment 1 Intervention

Group III: Base Intervention + Behavioral Interventions A + B + C Experimental Treatment 1 Intervention

Group IV: Base Intervention + Behavioral Interventions A + B Experimental Treatment 1 Intervention

Group V: Base Intervention + Behavioral Intervention C Experimental Treatment 1 Intervention

Group VI: Base Intervention + Behavioral Intervention B Experimental Treatment 1 Intervention

Group VII: Base Intervention + Behavioral Intervention A Experimental Treatment 1 Intervention

Group VIII: Base Intervention + No Experimental Behavioral Interventions Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4702019/

Kangaroo Mother Care and Neonatal Outcomes: A Meta- ... Newborns receiving KMC had lower mean respiratory rate and pain measures, and higher oxygen saturation, temperature, and head circumference growth. LIMITATIONS:.

2. who.int who.int/news/item/14-11-2025-who-promotes-lifesaving-intervention-for-small-and-preterm-babies-on-first-official-world-prematurity-day

WHO promotes lifesaving intervention for small and ... Among other positive impacts, it is associated with a more than 30% reduction in newborn deaths, a close to 70% reduction in hypothermia and a ...

3. med.stanford.edu med.stanford.edu/news/all-news/2024/08/kangaroo-preemies.html

Skin-to-skin 'kangaroo care' found to boost ... Babies born very early had stronger neurodevelopmental performance at 1 year if they received more skin-to-skin care as newborns, a Stanford Medicine study ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1355184125001152?dgcid=rss_sd_all

Kangaroo care practice outcome of mothers with premature ... The results showed that kangaroo care status, gestational age, birth weight, and length of hospitalization affected their MAI scores significantly. These ...

5. gh.bmj.com gh.bmj.com/content/8/6/e010728

Kangaroo mother care for preterm or low birth weight infants KMC initiated within 24 hours of birth reduces neonatal mortality and may reduce clinical sepsis until 28 days compared with later initiation. How this study ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10254798/

Kangaroo mother care for preterm or low birth weight infants The Cochrane review (2016) on kangaroo mother care (KMC) demonstrated a significant reduction in the risk of mortality in low birth weight infants.

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa2026486

Immediate “Kangaroo Mother Care” and Survival of Infants ... Approximately 45% of neonatal deaths occur within 24 hours after birth and 80% during the first week of life; thus, the majority of deaths among ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2352464225001300

All-cause mortality and infection-related outcomes of ... A 2023 systematic review and meta-analysis confirmed the mortality risk reduction with kangaroo care compared with conventional care in low-birthweight or ...

9. news.cornell.edu news.cornell.edu/stories/2025/09/skin-skin-contact-associated-brain-changes-preterm-infants

Skin-to-skin contact associated with brain changes in preterm ... “Kangaroo care,” or skin-to-skin contact, may be neuroprotective and is associated with neonatal development in areas of the brain involved ...