Massage Therapy for Premature Babies

Overseen By Johana Diaz, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Genetic syndromes, Cyanotic heart disease, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether Neonatal Touch and Massage Therapy can benefit premature babies in the NICU. Researchers aim to determine if this therapy helps babies get discharged sooner, gain weight more effectively, and manage pain and stress. They also examine its impact on brain development. Babies born prematurely, stable, and admitted to the University of Maryland NICU within their first two weeks of life qualify for participation. The therapy group will receive massage sessions in the NICU, and their progress will be compared to those receiving standard care to identify any benefits. As an unphased trial, this study provides a unique opportunity to explore innovative care options that could improve outcomes for premature infants.

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

The trial protocol does not specify whether participants must stop taking their current medications. However, since the trial involves premature babies, it is likely that any medication changes would be managed by the medical care team.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications. Since the trial involves premature babies, it is likely that any medication changes would be managed by the medical care team.

What prior data suggests that Neonatal Touch and Massage Therapy is safe for premature babies?

Research has shown that massage therapy is generally safe for premature babies when performed correctly. Studies indicate that this therapy can improve breathing and promote weight gain in babies. For instance, one study found that very small babies who received massage therapy gained about 63 grams on average. Additionally, massage therapy can strengthen the bond between a mother and her baby. Overall, massage therapy is considered safe, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about neonatal touch and massage therapy for premature babies because it offers a gentle, non-invasive approach to care. Unlike standard NICU care, which primarily focuses on medical interventions, this therapy involves structured touch and massage that can enhance bonding and emotional support. The treatment is designed to assess and potentially reduce pain and stress responses in these vulnerable infants, which could lead to improved developmental outcomes. By focusing on physical touch, this approach may provide benefits that traditional medical treatments do not address, such as enhancing neurological development and stabilizing vital signs.

What evidence suggests that Neonatal Touch and Massage Therapy is effective for premature babies?

Research has shown that Neonatal Touch and Massage Therapy, which participants in this trial may receive, can benefit premature babies. Studies have found that this therapy helps babies gain weight more quickly and reduces their hospital stay. For instance, one study found that preterm babies who received massage had better feeding, leading to more weight gain and shorter hospital stays. Another study found that massage therapy improved oxygen levels and strengthened the bond between mother and baby. Overall, these findings suggest that massage therapy can be a useful treatment for premature infants in the NICU. ^{1 3 6 7 8}

Who Is on the Research Team?

Johana Diaz, MD

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

This trial is for premature babies born between 23 and almost 32 weeks, who are medically stable and in the University of Maryland NICU within their first two weeks. Babies with life-threatening conditions, heart issues, those needing major surgery or critically ill at intervention time, or with certain bone problems can't join.

Inclusion Criteria

Infants born or admitted to University of Maryland NICU in the first 14 days of life

My baby was born between 24 and 31 weeks of pregnancy.

Deemed medically stable by the medical care team

Exclusion Criteria

I need major surgery or am critically ill right now.

I have a heart condition that causes bluish skin color.

I have a condition or genetic syndrome that could shorten my life.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Neonatal Touch and Massage Therapy 3 days a week for 5 to 15 minutes for a minimum of 4 weeks

4 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including developmental assessments at NICU follow-up clinic appointments

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Neonatal Touch and Massage Therapy

Trial Overview Researchers are testing if Neonatal Touch and Massage Therapy helps premature babies leave the NICU sooner compared to standard care. They're looking at weight gain, pain/stress response, and brain development outcomes.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

This group will receive structured neonatal touch or massage therapy from a certified NICU provider. Therapy will given 3 days a week for 5 to 15 minutes for a minimum of 4 weeks. We will also be collecting data to assess pain and stress responses during the period immediately before, during, and shortly after the therapy. This includes assessment of crying/irritability, behavior state, facial expression, extremities tone, and vital signs (heart rate, breathing rate, and oxygen levels).

Group II: Control Active Control 1 Intervention

This group will receive standard NICU care, no different than if they were not enrolled in the study.

Neonatal Touch and Massage Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Neonatal Touch and Massage Therapy for:

• Premature birth support
• Neonatal care
• NICU therapy

Approved in European Union as Infant Massage for:

• Premature infant development
• Parent-infant interaction support
• Neonatal intensive care

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

In a study of 24 preterm very low-birthweight newborns, massage therapy did not show significant overall benefits in motor development or weight gain compared to a sham treatment, but it did help infants with below-average motor performance.

Specifically, those infants receiving massage therapy had significantly greater improvements in motor scores and were discharged from the hospital earlier than those who received light touch, suggesting that massage therapy could be beneficial for certain high-risk newborns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of massage therapy on motor outcomes in very low-birthweight infants: randomized controlled pilot study. Ho, YB., Lee, RS., Chow, CB., et al.[2016]

Massage therapy with kinesthetic stimulation (M/KS) can enhance weight gain in preterm infants weighing more than 1000 grams, as shown in a study involving 60 medically stable premature infants.

However, neither massage alone nor massage with kinesthetic stimulation significantly affected the length of hospital stay for these infants, indicating that while massage may aid in growth, it does not shorten recovery time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Massage with kinesthetic stimulation improves weight gain in preterm infants. Massaro, AN., Hammad, TA., Jazzo, B., et al.[2009]

Infant massage therapy is a safe and effective intervention for preterm infants, leading to increased weight gain, improved developmental scores, and earlier hospital discharge, as supported by recent research.

In addition to benefits for the infants, massage therapy enhances parent-infant bonding and boosts parents' confidence in their caregiving abilities, making it a valuable practice in neonatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Premature infant massage in the NICU. Beachy, JM.[2007]

The study successfully developed and implemented a parent-trained massage program for infants with complex medical conditions in a neonatal intensive care unit, demonstrating its feasibility and safety, with no adverse effects on infant behavior or physiological measures during the sessions.

Caregivers reported high satisfaction with the massage program, indicating positive impacts on their relationship with their infants, suggesting that infant massage could be beneficial in enhancing caregiver-infant bonding in a NICU setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Touch and massage for medically fragile infants. Livingston, K., Beider, S., Kant, AJ., et al.[2020]

Massage therapy has been shown to significantly improve outcomes for premature infants, including increased body weight, reduced hospital stays, enhanced bone formation, and better behavior.

Nurses can effectively teach parents how to administer massage therapy, which not only benefits the infants but also strengthens the parent-child bond, suggesting that massage therapy should be integrated into future care programs for premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of massage therapy in premature infant nursing care]. Chang, SM., Sung, HC.[2009]

In a study of 78 preterm newborns, therapeutic touch significantly reduced the length of hospital stay from an average of 20.30 days in the control group to 16.82 days in the experimental group.

The incidence of complications was lower in the therapeutic touch group (5.3%) compared to the control group (20%), suggesting that this intervention may enhance the overall health outcomes for preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of the application of therapeutic touch on weight, complications, and length of hospital stay in preterm newborns attended in a neonatal unit]. Domínguez Rosales, R., Albar Marín, MJ., Tena García, B., et al.[2014]

Touch and massage for preterm infants in Neonatal Intensive Care Units can significantly enhance parent-infant bonding, which is crucial for emotional development.

Incorporating massage into family-centered care not only benefits the infants but also supports parents in their caregiving role, promoting overall well-being for the family.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baby massage: a dialogue of touch. Bond, C.[2019]

Massage therapy (MT) significantly enhances daily weight gain and growth velocity in preterm infants, with MT infants gaining an average of 19.3 g/day compared to 6.2 g/day in the routine care group.

MT leads to improved body composition, increasing total body mass, lean mass, and bone mineral density, which are associated with better long-term health outcomes for preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of tactile/kinesthetic massage therapy on growth and body composition of preterm infants. Elmoneim, MA., Mohamed, HA., Awad, A., et al.[2022]

Maternal massage therapy significantly reduced the incidence of late-onset sepsis in very-low-birth-weight infants, with only 10.8% of the intervention group affected compared to 38.3% in the control group.

Infants receiving maternal massage were discharged from the hospital 7 days earlier than those who did not receive the therapy, indicating that this intervention can improve recovery times for these vulnerable infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Massage therapy reduces hospital stay and occurrence of late-onset sepsis in very preterm neonates. Mendes, EW., Procianoy, RS.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11986174/

The Effects of Infant Massage Therapy on Preterm Neonatal ... Conclusion: Infant massage therapy significantly enhances weight gain and reduces the time to achieve full feeding in VLBW preterm infants. Moderate-pressure ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10500070/

Effects of massage therapy on preterm infants and their ... Massage therapy can significantly improve oxygen saturation and strengthen maternal-infant attachment.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1550830723002343

A follow up study on the effects of massage on preterm ... It was found that preterm infants who received massage had better amount of feeding, and this increased weight intake and reduced discharge time.

4. withpower.com withpower.com/trial/phase-neonatal-prematurity-10-2023-5223f

Massage Therapy for Premature Babies · Info for Participants Yes, Neonatal Touch and Massage Therapy is a promising treatment for premature babies. It helps them gain weight, improves their development, and allows them to ...

5. neonatalcertification.com neonatalcertification.com/site/wp-content/uploads/2019/04/References.pdf

Neonatal Massage in our NICU A., Hammad, T., Jazzo, B., Aly, H., (2009) Massage with kinesthetic stimulation improves weight gain in preterm infants. Journal of Perinatology. 29 (5). 352- ...

6. neonatalcertification.com neonatalcertification.com/about-ntmc/

About NTMC Certification | Neonatal Touch and Massage ... Neonatal Touch & Massage Certification (NTMC) is an exclusively neonatal, advanced, one-of-a-kind certification for neonatal healthcare providers.

7. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2023.1198730/full

Effects of massage therapy on preterm infants and their ... Massage therapy can significantly improve oxygen saturation and strengthen maternal-infant attachment.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0163638323000899

Effectiveness of infant massage on babies growth, mother ... Infant massage is an effective method that strengthens maternal attachment and increases body weight and height in infants.