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Effect of Tactile and Kinesthetic Stimulation on Very Low Birth Weight Preterm Infants

Primary Purpose

Preterm Birth

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Tactile stimulus
Sponsored by
National Bioethics Commission of Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Birth

Eligibility Criteria

1 Hour - 3 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: Major congenital malformations Congenital infectious diseases Mother not willing to participate in study

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm Description

tactile stimulus

Outcomes

Primary Outcome Measures

length of hospital stay

Secondary Outcome Measures

effect on beginning of enteral feedings
growth during hospitalization

Full Information

First Posted
August 8, 2005
Last Updated
February 4, 2008
Sponsor
National Bioethics Commission of Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT00128141
Brief Title
Effect of Tactile and Kinesthetic Stimulation on Very Low Birth Weight Preterm Infants
Official Title
Effect of Maternal Tactile and Kinesthetic Stimulation on Length of Hospital Stay of Very Low Birth Weight Infants
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Bioethics Commission of Brazil

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Title
2
Arm Type
Experimental
Arm Description
tactile stimulus
Intervention Type
Behavioral
Intervention Name(s)
Tactile stimulus
Other Intervention Name(s)
massage therapy
Intervention Description
four times a day
Primary Outcome Measure Information:
Title
length of hospital stay
Secondary Outcome Measure Information:
Title
effect on beginning of enteral feedings
Title
growth during hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Major congenital malformations Congenital infectious diseases Mother not willing to participate in study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renato S Procianoy, MD
Organizational Affiliation
Universidade Federal do Rio Grande do Sul-Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-005
Country
Brazil

12. IPD Sharing Statement

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Effect of Tactile and Kinesthetic Stimulation on Very Low Birth Weight Preterm Infants

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