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

Not Applicable

Completed

• Conditions: Preterm Birth
• Interventions: Behavioral: Tactile stimulus

• Registration Number: NCT00128141
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2003-08
• Study First Submitted: 2005-08-08
• Study First Submitted QC: 2005-08-08
• Study First Posted: 2005-08-09
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-04
• Last Update Posted: 2008-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Tactile stimulus	tactile stimulus

Primary Outcome Measures

Name	Time	Method
length of hospital stay

Secondary Outcome Measures

Name	Time	Method
effect on beginning of enteral feedings
growth during hospitalization

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil