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
  Purpose

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 Intervention
Preterm Birth
Behavioral: Tactile stimulus

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by National Bioethics Commission of Brazil:

Primary Outcome Measures:
  • length of hospital stay [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • effect on beginning of enteral feedings [ Designated as safety issue: No ]
  • growth during hospitalization [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: August 2003
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Experimental: 2
tactile stimulus
Behavioral: Tactile stimulus
four times a day
Other Name: massage therapy

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.

  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Renato S. Procianoy, Hospital de Clinicas de Porto Alegrte
ClinicalTrials.gov Identifier: NCT00128141     History of Changes
Other Study ID Numbers: HCPA03287
Study First Received: August 8, 2005
Last Updated: February 4, 2008
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on April 21, 2014