PrematurityNCT00661791
Effects of Massage Therapy and Kinesthetic Stimulation on Pre-Term Infants
A study testing Massage therapy without exercise and Massage therapy with exercise in people with Prematurity, run by George Washington University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 to 32 weeks
- Conditions the study is for
- Prematurity
- What is being tested?
- Massage therapy without exercise and Massage therapy with exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- infants with major congenital anomaly
- those that require mechanical ventilatory support
- those that are restricted in their movement or ability to undergo the intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University Hospital
Washington D.C., District of Columbia, 20037
About this study
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.
Read the detailed description
Premature infants are often cared for in a fashion that minimizes physical activity in order to reduce stress and stress-related complications. Previous studies have indicated that massage therapy may increase weight gain and enabled earlier discharge of premature infants.
In this study, premature infants were randomly assigned to one of three groups:
A: Control Group
B: Massage Group, 15 minutes twice a day;
C: Massage and physical exercise group 15 minutes each, twice a day.
- Conditions
- Prematurity
- Being tested
- Massage therapy without exercise, Massage therapy with exercise
- Keywords
- preterm infants, massage, physical activity, weight gain, length of hospital stay, NICU
- Medical subject headings
- Premature Birth, Motor Activity, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage therapy without exerciseBehavioural
Infants will receive massage twice a day; 15 minutes each.
Massage therapy with exerciseBehavioural
Infants will receive massage with exercise twice a day; 15 minutes each.
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | Control Group receives routine care. |
| B. | Experimental | massage group, receives massage only. Receives: Behavioral: Massage therapy without exercise |
| C. | Experimental | Massage and Exercise group, receives both massage and exercise. Receives: Behavioral: Massage therapy with exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily weight gain. Length of hospital stay
Measured: From birth until time of hospital discharge
Secondary outcomes (1)
Effect on heart rate and respirations
Measured: Birth until time of hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startFeb 2003
- Primary completionApr 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Investigators
- Hany Z Aly, MD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661791
- Sponsor's protocol ID
- IRB120206
- Status last verified
- Apr 2008
- First submitted
- 15 Apr 2008
- Last updated
- 18 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Massage Therapy and Kinesthetic Stimulation on Pre-Term Infants
- ClinicalTrials.gov ID
- NCT00661791
- Acronym / sponsor ID
- IRB120206
- Conditions
- Prematurity
- Keywords
- preterm infants, massage, physical activity, weight gain, length of hospital stay, NICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Apr 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 18 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Premature infants are often cared for in a fashion that minimizes physical activity in order to reduce stress and stress-related complications. Previous studies have indicated that massage therapy may increase weight gain and enabled earlier discharge of premature infants.
In this study, premature infants were randomly assigned to one of three groups:
A: Control Group
B: Massage Group, 15 minutes twice a day;
C: Massage and physical exercise group 15 minutes each, twice a day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | –Control Group receives routine care. |
| B. | Experimental | Behavioral: Massage therapy without exercisemassage group, receives massage only. |
| C. | Experimental | Behavioral: Massage therapy with exerciseMassage and Exercise group, receives both massage and exercise. |
Who may qualify
- Ages
- 28 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- infants with major congenital anomaly
- those that require mechanical ventilatory support
- those that are restricted in their movement or ability to undergo the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage therapy without exerciseInfants will receive massage twice a day; 15 minutes each. | Behavioural | B. |
| Massage therapy with exerciseInfants will receive massage with exercise twice a day; 15 minutes each. | Behavioural | C. |
Primary outcome
Average daily weight gain. Length of hospital stay
Time frame: From birth until time of hospital discharge
1 secondary outcome
Effect on heart rate and respirations
Time frame: Birth until time of hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hany Z Aly, MD principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage therapy without exercise and Massage therapy with exercise in people with Prematurity, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average daily weight gain. Length of hospital stay (time frame: From birth until time of hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2008.