Massage Therapy in Premature Neonates

NCT06163586 | Completed

• 1 other identifier: HP-00098293
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neonatal Prematurity; Massage Therapy

Keywords

Prematurity; Massage therapy

Outcome Measures

Primary Outcomes (1)

• Length of stay

  Total length of hospitalization, from NICU admission to discharge home in days

  Day of birth to discharge home, up to 6 months

Secondary Outcomes (5)

• Weight gain

  Through study intervention, an average of 4 weeks

• Linear growth

  Through study intervention, an average of 4 weeks

• Head growth

  Through study intervention, an average of 4 weeks

• Neurodevelopmental Outcomes

  Within in 1 week of NICU discharge or transfer until up to 3 years of age

• Pain scores

  1 hour before intervention and up to 3 hours post-intervention

Study Arms (2)

Intervention

EXPERIMENTAL

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).

Other: Neonatal Touch and Massage Therapy

Control

NO INTERVENTION

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

Interventions

Neonatal Touch and Massage Therapy OTHER

Structured touch and massage therapy performed by certified providers.

Intervention

Eligibility Criteria

• Age: 24 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants born or admitted to University of Maryland NICU in the first 14 days of life
• Gestational age greater than 23 6/7 weeks and less than 32 weeks at birth
• Deemed medically stable by the medical care team

You may not qualify if:

• Life limiting conditions, including genetic syndromes
• Cyanotic heart disease
• Requiring major surgery or critically ill at time of intervention
• Osteopenia of prematurity with an existing fracture

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (24)

• Lago P, Garetti E, Merazzi D, Pieragostini L, Ancora G, Pirelli A, Bellieni CV; Pain Study Group of the Italian Society of Neonatology. Guidelines for procedural pain in the newborn. Acta Paediatr. 2009 Jun;98(6):932-9. doi: 10.1111/j.1651-2227.2009.01291.x.

  PMID: 19484828 BACKGROUND

• Leslie Altimier, RN, MSN, DNPc, NEA-BC, Raylene M. Phillips, MD, MA, IBCLC, FAAP. The Neonatal Integrative Developmental Care Model: Seven Neuroprotective Core Measures for Family-Centered Developmental Care. Newborn & Infant Nursing Reviews 13 (2013) 9-22.

  BACKGROUND

• Pickler RH, McGrath JM, Reyna BA, McCain N, Lewis M, Cone S, Wetzel P, Best A. A model of neurodevelopmental risk and protection for preterm infants. J Perinat Neonatal Nurs. 2010 Oct-Dec;24(4):356-65. doi: 10.1097/JPN.0b013e3181fb1e70.

  PMID: 21045616 BACKGROUND

• Cruz MD, Fernandes AM, Oliveira CR. Epidemiology of painful procedures performed in neonates: A systematic review of observational studies. Eur J Pain. 2016 Apr;20(4):489-98. doi: 10.1002/ejp.757. Epub 2015 Jul 29.

  PMID: 26223408 BACKGROUND

• Lai MM, D'Acunto G, Guzzetta A, Boyd RN, Rose SE, Fripp J, Finnigan S, Ngenda N, Love P, Whittingham K, Pannek K, Ware RS, Colditz PB. PREMM: preterm early massage by the mother: protocol of a randomised controlled trial of massage therapy in very preterm infants. BMC Pediatr. 2016 Aug 27;16(1):146. doi: 10.1186/s12887-016-0678-7.

  PMID: 27568006 RESULT

• Williams MD, Lascelles BDX. Early Neonatal Pain-A Review of Clinical and Experimental Implications on Painful Conditions Later in Life. Front Pediatr. 2020 Feb 7;8:30. doi: 10.3389/fped.2020.00030. eCollection 2020.

  PMID: 32117835 RESULT

• Badr LK, Abdallah B, Kahale L. A Meta-Analysis of Preterm Infant Massage: An Ancient Practice With Contemporary Applications. MCN Am J Matern Child Nurs. 2015 Nov-Dec;40(6):344-58. doi: 10.1097/NMC.0000000000000177.

  PMID: 26302088 RESULT

• Mrljak R, Arnsteg Danielsson A, Hedov G, Garmy P. Effects of Infant Massage: A Systematic Review. Int J Environ Res Public Health. 2022 May 24;19(11):6378. doi: 10.3390/ijerph19116378.

  PMID: 35681968 RESULT

• Niemi AK. Review of Randomized Controlled Trials of Massage in Preterm Infants. Children (Basel). 2017 Apr 3;4(4):21. doi: 10.3390/children4040021.

  PMID: 28368368 RESULT

• Stoll BJ, Hansen NI, Bell EF, Shankaran S, Laptook AR, Walsh MC, Hale EC, Newman NS, Schibler K, Carlo WA, Kennedy KA, Poindexter BB, Finer NN, Ehrenkranz RA, Duara S, Sanchez PJ, O'Shea TM, Goldberg RN, Van Meurs KP, Faix RG, Phelps DL, Frantz ID 3rd, Watterberg KL, Saha S, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network. Pediatrics. 2010 Sep;126(3):443-56. doi: 10.1542/peds.2009-2959. Epub 2010 Aug 23.

  PMID: 20732945 RESULT

• Alvarez MJ, Fernandez D, Gomez-Salgado J, Rodriguez-Gonzalez D, Roson M, Lapena S. The effects of massage therapy in hospitalized preterm neonates: A systematic review. Int J Nurs Stud. 2017 Apr;69:119-136. doi: 10.1016/j.ijnurstu.2017.02.009. Epub 2017 Feb 14.

  PMID: 28235686 RESULT

• McGowan EC, Hofheimer JA, O'Shea TM, Kilbride H, Carter BS, Check J, Helderman J, Neal CR, Pastyrnak S, Smith LM, Camerota M, Dansereau LM, Della Grotta SA, Lester BM. Analysis of Neonatal Neurobehavior and Developmental Outcomes Among Preterm Infants. JAMA Netw Open. 2022 Jul 1;5(7):e2222249. doi: 10.1001/jamanetworkopen.2022.22249.

  PMID: 35849396 RESULT

• Santos J, Pearce SE, Stroustrup A. Impact of hospital-based environmental exposures on neurodevelopmental outcomes of preterm infants. Curr Opin Pediatr. 2015 Apr;27(2):254-60. doi: 10.1097/MOP.0000000000000190.

  PMID: 25635585 RESULT

• Field T, Diego M, Hernandez-Reif M. Preterm infant massage therapy research: a review. Infant Behav Dev. 2010 Apr;33(2):115-24. doi: 10.1016/j.infbeh.2009.12.004.

  PMID: 20137814 RESULT

• Agarwal KN, Gupta A, Pushkarna R, Bhargava SK, Faridi MM, Prabhu MK. Effects of massage & use of oil on growth, blood flow & sleep pattern in infants. Indian J Med Res. 2000 Dec;112:212-7.

  PMID: 11247199 RESULT

• Arora J, Kumar A, Ramji S. Effect of oil massage on growth and neurobehavior in very low birth weight preterm neonates. Indian Pediatr. 2005 Nov;42(11):1092-100.

  PMID: 16340050 RESULT

• Fallah R, Akhavan Karbasi S, Golestan M, Fromandi M. Sunflower oil versus no oil moderate pressure massage leads to greater increases in weight in preterm neonates who are low birth weight. Early Hum Dev. 2013 Sep;89(9):769-72. doi: 10.1016/j.earlhumdev.2013.06.002. Epub 2013 Jul 5.

  PMID: 23830725 RESULT

• Saeadi R, Ghorbani Z, Shapouri Moghaddam A. The effect of massage with medium-chain triglyceride oil on weight gain in premature neonates. Acta Med Iran. 2015;53(2):134-8.

  PMID: 25725185 RESULT

• Wang L, He JL, Zhang XH. The efficacy of massage on preterm infants: a meta-analysis. Am J Perinatol. 2013 Oct;30(9):731-8. doi: 10.1055/s-0032-1332801. Epub 2013 Jan 15.

  PMID: 23322391 RESULT

• Vickers A, Ohlsson A, Lacy JB, Horsley A. Massage for promoting growth and development of preterm and/or low birth-weight infants. Cochrane Database Syst Rev. 2004;2004(2):CD000390. doi: 10.1002/14651858.CD000390.pub2.

  PMID: 15106151 RESULT

• Procianoy RS, Mendes EW, Silveira RC. Massage therapy improves neurodevelopment outcome at two years corrected age for very low birth weight infants. Early Hum Dev. 2010 Jan;86(1):7-11. doi: 10.1016/j.earlhumdev.2009.12.001. Epub 2009 Dec 22.

  PMID: 20022717 RESULT

• Fitri SYR, Nasution SK, Nurhidayah I, Maryam NNA. Massage therapy as a non-pharmacological analgesia for procedural pain in neonates: A scoping review. Complement Ther Med. 2021 Jun;59:102735. doi: 10.1016/j.ctim.2021.102735. Epub 2021 May 8.

  PMID: 33974990 RESULT

• Bernstein K, Karkhaneh M, Zorzela L, Jou H, Vohra S. Massage therapy for paediatric procedural pain: A rapid review. Paediatr Child Health. 2019 Nov 1;26(1):e57-e66. doi: 10.1093/pch/pxz133. eCollection 2021 Feb.

  PMID: 33542780 RESULT

• Hummel P, Puchalski M, Creech SD, Weiss MG. Clinical reliability and validity of the N-PASS: neonatal pain, agitation and sedation scale with prolonged pain. J Perinatol. 2008 Jan;28(1):55-60. doi: 10.1038/sj.jp.7211861. Epub 2007 Oct 25.

  PMID: 18165830 RESULT

MeSH Terms

Conditions

Premature Birth

Interventions

Massage

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Johana Diaz, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors evaluating neurodevelopmental outcomes will be masked from knowing which intervention was assigned to individual participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of pediatrics, Division of neonatology, University of Maryland

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: December 11, 2023
• Study Start: November 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)