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

Preterm Birth Clinical Trial

Official title:

Effect of Maternal Tactile and Kinesthetic Stimulation on Length of Hospital Stay of Very Low Birth Weight Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128141
• Other study ID #: HCPA03287
• Status: Completed
• Phase: N/A
• First received: August 8, 2005
• Last updated: February 4, 2008
• Start date: August 2003
• Est. completion date: November 2005

Study information

• Verified date: February 2008
• Source: National Bioethics Commission of Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birth Weight
• Premature Birth
• Preterm Birth

Intervention

Behavioral:
• Tactile stimulus
four times a day

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
National Bioethics Commission of Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of hospital stay			No
Secondary	effect on beginning of enteral feedings			No
Secondary	growth during hospitalization			No