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

This study has been completed.
Sponsor:
Information provided by:
National Bioethics Commission of Brazil
ClinicalTrials.gov Identifier:
NCT00128141
First received: August 8, 2005
Last updated: February 4, 2008
Last verified: February 2008
History of Changes

August 8, 2005
February 4, 2008
August 2003
November 2005   (final data collection date for primary outcome measure)
length of hospital stay [ Designated as safety issue: No ]
effect on growth of very low birth weight preterm infants
Complete list of historical versions of study NCT00128141 on ClinicalTrials.gov Archive Site
  • effect on beginning of enteral feedings [ Designated as safety issue: No ]
  • growth during hospitalization [ Designated as safety issue: No ]
  • effect on beginning of entereal feedings
  • effect on length of hospital stay
Not Provided
Not Provided
 
Effect of Tactile and Kinesthetic Stimulation on Very Low Birth Weight Preterm Infants
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Preterm Birth
Behavioral: Tactile stimulus
four times a day
Other Name: massage therapy
  • No Intervention: 1
  • Experimental: 2
    tactile stimulus
    Intervention: Behavioral: Tactile stimulus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
November 2005
November 2005   (final data collection date for primary outcome measure)

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
Both
up to 3 Days
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00128141
HCPA03287
No
Renato S. Procianoy, Hospital de Clinicas de Porto Alegrte
National Bioethics Commission of Brazil
Not Provided
Principal Investigator: Renato S Procianoy, MD Universidade Federal do Rio Grande do Sul-Hospital de Clínicas de Porto Alegre
National Bioethics Commission of Brazil
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP