ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00128141
Recruitment Status : Completed
First Posted : August 9, 2005
Last Update Posted : February 5, 2008
Sponsor:
Information provided by:
National Bioethics Commission of Brazil

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.

Condition or disease Intervention/treatment Phase
Preterm Birth Behavioral: Tactile stimulus Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Maternal Tactile and Kinesthetic Stimulation on Length of Hospital Stay of Very Low Birth Weight Infants
Study Start Date : August 2003
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 1
Experimental: 2
tactile stimulus
Behavioral: Tactile stimulus
four times a day
Other Name: massage therapy



Primary Outcome Measures :
  1. length of hospital stay

Secondary Outcome Measures :
  1. effect on beginning of enteral feedings
  2. growth during hospitalization


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128141


Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-005
Sponsors and Collaborators
National Bioethics Commission of Brazil
Investigators
Principal Investigator: Renato S Procianoy, MD Universidade Federal do Rio Grande do Sul-Hospital de Clínicas de Porto Alegre

Responsible Party: Renato S. Procianoy, Hospital de Clinicas de Porto Alegrte
ClinicalTrials.gov Identifier: NCT00128141     History of Changes
Other Study ID Numbers: HCPA03287
First Posted: August 9, 2005    Key Record Dates
Last Update Posted: February 5, 2008
Last Verified: February 2008

Additional relevant MeSH terms:
Premature Birth
Birth Weight
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Body Weight
Signs and Symptoms