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

32 Participants Needed

Trial Summary

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 data supports the idea that Massage Therapy for Premature Babies is an effective treatment?

The available research shows that massage therapy for premature babies can lead to positive outcomes. One study found that massage therapy improved motor development, helped with weight gain, and led to earlier hospital discharge for very low-birthweight infants. Another study highlighted that massage therapy reduced the length of hospital stay and decreased the occurrence of late-onset sepsis, a serious infection, in very preterm babies. Additionally, massage with kinesthetic stimulation was shown to improve weight gain in preterm infants. These findings suggest that massage therapy is an effective treatment for premature babies, offering benefits like faster weight gain and shorter hospital stays compared to not using this therapy. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Neonatal Touch and Massage Therapy for premature babies?

Research shows that massage therapy can help premature babies gain weight faster, improve their motor skills, and reduce their hospital stay. It also helps in reducing complications like late-onset sepsis (a severe infection) and enhances bonding between parents and their babies. ^{1 2 3 4 5}

What safety data exists for massage therapy in premature babies?

Research indicates that massage therapy for premature infants is generally safe when properly applied. Studies have shown that it can lead to increased weight gain, improved developmental scores, and earlier hospital discharge. Safety is supported by findings of physiological stability and no increase in agitation or pain scores during massage sessions. Caregivers and healthcare providers report high satisfaction with the therapy, and it is considered feasible and safe in neonatal intensive care settings. ^{1 2 3 6 7}

Is massage therapy safe for premature babies?

Recent research suggests that massage therapy for premature babies is generally safe when properly applied. Studies have shown that it can lead to benefits like increased weight gain and improved development, with minimal risks, and caregivers report high satisfaction with the therapy. ^{1 2 3 6 7}

Is Neonatal Touch and Massage Therapy a promising treatment for premature babies?

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 leave the hospital earlier. It also strengthens the bond between parents and their babies, boosting parents' confidence in caring for their child. ^{2 4 6 8 9}

How is the treatment Neonatal Touch and Massage Therapy unique for premature babies?

Neonatal Touch and Massage Therapy is unique because it combines multiple sensory stimulations (auditory, tactile, visual, and vestibular) to promote growth, improve developmental scores, and enhance bonding between parents and their premature infants, which is not typically addressed by other treatments. ^{2 4 6 8 9}

What is the purpose of this trial?

The goal of this clinical trial is to learn about the effects of Neonatal Touch and Massage Therapy on premature babies. The main questions it aims to answer are: * Do babies who receive Neonatal Touch and Massage Therapy get discharged sooner from the NICU * Does Neonatal Touch and Massage Therapy have a beneficial effect on weight gain, pain and stress responses, and neurodevelopmental outcomes. Participants assigned to the treatment group will receive Neonatal Touch and Massage Therapy while admitted to the NICU. Researchers will compare their outcomes to a control group, receiving standard NICU care, to see if there are any differences in the length of hospital stay, weight gain, pain scores, neurodevelopmental outcomes, and incidence of other common conditions associated with prematurity.

Research Team

Johana Diaz, MD

Principal Investigator

University of Maryland, Baltimore

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Massage with kinesthetic stimulation improves weight gain in preterm infants. [2009]

2. Australia pubmed.ncbi.nlm.nih.gov

Impact of massage therapy on motor outcomes in very low-birthweight infants: randomized controlled pilot study. [2016]

3. Spain 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]. [2014]

4. England pubmed.ncbi.nlm.nih.gov

Baby massage: a dialogue of touch. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Premature infant massage in the NICU. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Touch and massage for medically fragile infants. [2020]

8. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

[Application of massage therapy in premature infant nursing care]. [2009]

9. Germany pubmed.ncbi.nlm.nih.gov

Effect of tactile/kinesthetic massage therapy on growth and body composition of preterm infants. [2022]