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

NCT ID: NCT00128141

Last Updated: 2008-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2005-11-30

Brief Summary

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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

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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.

Conditions

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Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type NO_INTERVENTION

No interventions assigned to this group

2

tactile stimulus

Group Type EXPERIMENTAL

Tactile stimulus

Intervention Type BEHAVIORAL

four times a day

Interventions

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Tactile stimulus

four times a day

Intervention Type BEHAVIORAL

Other Intervention Names

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massage therapy

Eligibility Criteria

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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
Minimum Eligible Age

1 Hour

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Bioethics Commission of Brazil

OTHER

Sponsor Role lead

Responsible Party

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Hospital de Clinicas de Porto Alegrte

Principal Investigators

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Renato S Procianoy, MD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio Grande do Sul-Hospital de Clínicas de Porto Alegre

Locations

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Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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HCPA03287

Identifier Type: -

Identifier Source: org_study_id

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