Skin-to-Skin Contact for Premature Birth

Not currently recruiting at 3 trial locations

Overseen By Håkon Bergseng, md phd

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Norwegian University of Science and Technology

Disqualifiers: Immediate medical interventions

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how skin-to-skin contact with the mother affects premature babies compared to standard incubator care. Researchers aim to determine if this contact improves vital signs such as body temperature and heart rate, while also observing the babies' movements and emotions. They will compare babies receiving skin-to-skin contact immediately after birth with those receiving standard care in the neonatal intensive care unit. Preterm infants born 8 to 12 weeks early, who do not require immediate medical interventions, are suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to enhance understanding of the benefits of maternal contact for preterm infants.

Do I need to stop my current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that skin-to-skin contact, or "kangaroo care," is safe for premature babies. Studies have found that this method can strengthen the bond between mother and baby and improve the baby's brain development. It may also aid brain growth and reduce the risk of death in babies with low birth weight. These findings suggest that skin-to-skin contact is well-received and benefits both the baby and the mother. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about skin-to-skin contact for premature birth because it offers a natural and immediate bonding experience that might enhance the baby's development and stability. Unlike the standard care, which involves transferring the baby to a neonatal intensive care unit, skin-to-skin contact allows the newborn to remain on the mother's chest for up to two hours. This method could improve the baby's heart rate, temperature regulation, and overall comfort by mimicking the warm, secure environment of the womb.

What evidence suggests that skin-to-skin contact might be an effective treatment for premature birth?

This trial will compare skin-to-skin contact, known as "kangaroo care," with standard care for premature babies. Research has shown that skin-to-skin contact can greatly benefit babies born early. Studies have found that this method can lead to better brain development by the time the baby reaches one year of age. For babies with low birth weight, kangaroo care is associated with a 36% lower risk of death compared to regular care. It also boosts the mother's confidence and reduces her risk of depression. Although some studies did not find long-term brain development improvements, evidence strongly supports the overall benefits for early survival and emotional well-being. ^{2 3 5 6 7}

Who Is on the Research Team?

Håkon Bergseng, md phd

Principal Investigator

Norwegian University of Science and Technology

Are You a Good Fit for This Trial?

This trial is for preterm infants born between 28-32 weeks of gestation. It's not suitable for those needing immediate medical interventions after birth.

Inclusion Criteria

My baby was born between 28 and 32 weeks of pregnancy.

Exclusion Criteria

My infant requires immediate medical care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Preterm infants receive skin-to-skin contact with the mother or standard care in an incubator immediately after birth

Up to 2 hours

1 visit (in-person)

Initial Follow-up

Infants are monitored for physiological and social/emotional responses, including video recording during the first 24 hours and at three months of age

3 months

Multiple visits (in-person)

Long-term Follow-up

Assessment of cognitive development, social/emotional competence, and other developmental skills at one and two years corrected age

2 years

What Are the Treatments Tested in This Trial?

Interventions

• skin-to-skin
• standard care

Trial Overview The study compares the effects of skin-to-skin contact with standard care in an incubator on preterm infants' physiological and emotional responses, as well as their general movements.

How Is the Trial Designed?

Group I: skin-to-skin Experimental Treatment 1 Intervention

immediately after birth the baby is laid on mother's chest for as long as justifiable medically to max 2 hours.

Group II: standard care Active Control 1 Intervention

after birth the baby is transferred to the neonatal intensive care unit

Who Is Running the Clinical Trial?

Norwegian University of Science and Technology

Lead Sponsor

Trials

673

Recruited

2,187,000+

Drammen sykehus

Collaborator

Trials

15

Recruited

101,000+

IWK Health Centre

Collaborator

Trials

131

Recruited

112,000+

Sorlandet Hospital HF

Collaborator

Trials

122

Recruited

92,100+

St. Olavs Hospital

Collaborator

Trials

549

Recruited

309,000+

Citations

1. 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 ...

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

Kangaroo Mother Care and Neonatal Outcomes: A Meta- ... Among LBW newborns, KMC compared to conventional care was associated with 36% lower mortality(RR 0.64; 95% [CI] 0.46, 0.89). KMC decreased risk of neonatal ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2832848

Immediate Skin-to-Skin Contact in Very Preterm Neonates ... In this randomized clinical trial, 2 hours of mother-neonate SSC in the delivery room did not enhance neurodevelopmental outcomes at 2 to 3 years of age.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1355184125001152

Kangaroo care practice outcome of mothers with premature ... Mothers providing kangaroo care are likely to have higher self-confidence, competence, and self-esteem and lower rates of maternal depression (Schrauwen et al., ...

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

Immediate “Kangaroo Mother Care” and Survival of Infants ... “Kangaroo mother care,” a type of newborn care involving skin-to-skin contact with the mother or other caregiver, reduces mortality in infants with low birth ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10047376/

Early Skin-to-Skin Contact in Preterm Infants: Is It Safe? An ... A quasi-experimental study demonstrated that the rate of maternal attachment was significantly higher in mothers who experienced skin-to-skin ...

7. 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 ...