Preterm BirthNCT00128141
Effect of Tactile and Kinesthetic Stimulation on Very Low Birth Weight Preterm Infants
A study testing Tactile stimulus in people with Preterm Birth, run by National Bioethics Commission of Brazil at 1 site in Brazil.
Trial summary
Two groups of preterm infants with birth weight equal to or less than 1500 grams will be studied. One group will receive the standard care and the other will receive standard care plus maternal special tactile stimulation. Read more about this study
- Who is it for?
- Ages 1 hour to 3 days
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Tactile stimulus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2003to Nov 2005
- 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 1 hour to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm newborns with birth weight equal to or less than 1500 grams and gestational age equal to or less than 32 weeks.
- Mother willing to participate in study.
Who cannot join
- Major congenital malformations
- Congenital infectious diseases
- Mother not willing to participate in study
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-005
About this study
Official title: Effect of Maternal Tactile and Kinesthetic Stimulation on Length of Hospital Stay of Very Low Birth Weight Infants
Two groups of preterm infants with birth weight equal to or less than 1500 grams will be studied. One group will receive the standard care and the other will receive standard care plus maternal special tactile stimulation. Gain of weight, length and head circumference, date of the beginning of enteral feedings, length of time to recover birth weight and age of hospital discharge will be recorded and compared between both groups.
Read the detailed description
Preterm infants birth weight equal or less than 1500 grams and gestational age equal or less than 32 weeks will be randomized in two groups: standard care that will receive the usual treatment applied to all infants admitted to our unit and a second groups that will receive standard care plus maternal tactile and kinesthetic stimuli that will be taught to the mothers. Randomization will be performed among those that accept to participate in the study. Growth (birth, length and head circumference), age of life to start receiving enteral feedings, length of hospital stay, time to recover birth weight will be recorded and compared between both groups.
- Conditions
- Preterm Birth
- Being tested
- Tactile stimulus
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactile stimulusBehavioural
Also called massage therapy
four times a day
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described |
| 2 | Experimental | tactile stimulus Receives: Behavioral: Tactile stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of hospital stay
Secondary outcomes (2)
effect on beginning of enteral feedings
growth during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2005 (estimated)
- Study startAug 2003
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Bioethics Commission of Brazil
- Sponsor type
- University, hospital or other
- Investigators
- Renato S Procianoy, MD, Principal investigator, Universidade Federal do Rio Grande do Sul-Hospital de Clínicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128141
- Sponsor's protocol ID
- HCPA03287
- Status last verified
- Feb 2008
- First submitted
- 8 Aug 2005
- Last updated
- 5 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Maternal Tactile and Kinesthetic Stimulation on Length of Hospital Stay of Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT00128141
- Acronym / sponsor ID
- HCPA03287
- Conditions
- Preterm Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- National Bioethics Commission of BrazilUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 9 Aug 2005 (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.
Two groups of preterm infants with birth weight equal to or less than 1500 grams will be studied. One group will receive the standard care and the other will receive standard care plus maternal special tactile stimulation. Gain of weight, length and head circumference, date of the beginning of enteral feedings, length of time to recover birth weight and age of hospital discharge will be recorded and compared between both groups.
Detailed description
Preterm infants birth weight equal or less than 1500 grams and gestational age equal or less than 32 weeks will be randomized in two groups: standard care that will receive the usual treatment applied to all infants admitted to our unit and a second groups that will receive standard care plus maternal tactile and kinesthetic stimuli that will be taught to the mothers. Randomization will be performed among those that accept to participate in the study. Growth (birth, length and head circumference), age of life to start receiving enteral feedings, length of hospital stay, time to recover birth weight will be recorded and compared between both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | – |
| 2 | Experimental | Behavioral: Tactile stimulustactile stimulus |
Who may qualify
- Ages
- 1 hour to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm newborns with birth weight equal to or less than 1500 grams and gestational age equal to or less than 32 weeks.
- Mother willing to participate in study.
Key exclusion criteria (3 listed)
- Major congenital malformations
- Congenital infectious diseases
- Mother not willing to participate in study
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 |
|---|---|---|
| Tactile stimulusAlso: massage therapyfour times a day | Behavioural | 2 |
Primary outcome
length of hospital stay
2 secondary outcomes
effect on beginning of enteral feedings
growth during hospitalization
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 5 Feb 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.
Renato S Procianoy, MD principal investigator
Universidade Federal do Rio Grande do Sul-Hospital de Clínicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tactile stimulus in people with Preterm Birth, run by National Bioethics Commission of Brazil at 1 site in Brazil.
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 2 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 5 Feb 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 Brazil. 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?
length of hospital stay. 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 5 Feb 2008.