Effects of Massage Therapy and Kinesthetic Stimulation on Pre-Term Infants

NCT00661791 | Completed

• 1 other identifier: IRB120206
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to determine whether massage with or without physical exercise impacted weight gain or length of hospital stay for premature infants.

Conditions

Prematurity

Keywords

preterm infants; massage; physical activity; weight gain; length of hospital stay; NICU

Outcome Measures

Primary Outcomes (1)

• Average daily weight gain. Length of hospital stay

  From birth until time of hospital discharge

Secondary Outcomes (1)

• Effect on heart rate and respirations

  Birth until time of hospital discharge

Study Arms (3)

A

NO INTERVENTION

Control Group receives routine care.

B.

EXPERIMENTAL

massage group, receives massage only.

Behavioral: Massage therapy without exercise

C.

EXPERIMENTAL

Massage and Exercise group, receives both massage and exercise.

Behavioral: Massage therapy with exercise

Interventions

Massage therapy without exercise BEHAVIORAL

Infants will receive massage twice a day; 15 minutes each.

B.

Massage therapy with exercise BEHAVIORAL

Infants will receive massage with exercise twice a day; 15 minutes each.

C.

Eligibility Criteria

• Age: 28 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• low birth weight, less than 1500 grams
• weight of at least 1000 grams at time of entry into study
• must be at least one week of age
• must have relative medical stability
• gestational age between 28-32 weeks

You may not qualify if:

• infants with major congenital anomaly
• those that require mechanical ventilatory support
• those that are restricted in their movement or ability to undergo the intervention

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Premature Birth; Motor Activity; Weight Gain

Interventions

Massage; Exercise

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hany Z Aly, MD

  George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 15, 2008
• First Posted: April 18, 2008
• Study Start: February 1, 2003
• Primary Completion: April 1, 2007
• Study Completion: October 1, 2007
• Last Updated: April 18, 2008

Record last verified: 2008-04

Locations

US (1)