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


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

This study is currently recruiting patients.
Verified by National Bioethics Commission of Brazil August 2003

Sponsored by: National Bioethics Commission of Brazil
Information provided by: National Bioethics Commission of Brazil
ClinicalTrials.gov Identifier: NCT00128141

Purpose

Two groups of preterm infants with birthweight equal or less than 1500 grams will be studied. One group will receive the standard care and the other wil receive standard care plus maternal special tactile stimulation. It will be measured growth, beginning of enteral feedings, time to recover birth weight and age of hospital discharge.
Condition Intervention
Preterm Birth
 Behavior: Tactile stimulus

MedlinePlus related topics:  High Risk Pregnancy

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 
Primary Outcomes: effect on growth of very low birth weight preterm infants
Secondary Outcomes: effect on beginning of entereal feedings; effect on length of hospital stay
Expected Total Enrollment:  106

Study start: August 2003;  Expected completion: August 2006
Last follow-up: January 2006;  Data entry closure: March 2006

Preterm infants birth weight equal or less tan 1500 grams and gestational age equal or less than 32 weeks wil be randomized to 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
Criteria

Inclusion Criteria:

  • Preterm newborns with birth weight equal or less than 1500 grams and gestational age equal or less than 32 weeks.
  • Mother willing to participate of study.

Exclusion Criteria:

  • Major congenital malformations
  • Congenital infectious diseases
  • Mother not willing to participate of study

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00128141

Eliane W Mendes, RN      55-51-21018142    emendes@hcpa.ufrgs.br

Brazil, RS
      Hospital de Clínicas de Porto Alegre, Porto Alegre,  RS,  90035-005,  Brazil; Recruiting
Eliane W Mendes, RN  55-51-21018142    emendes@hcpa.ufrgs.br 
Renato S Procianoy, MD,  Principal Investigator

Study chairs or principal investigators

Renato S Procianoy, MD,  Principal Investigator,  Universidade Federal do Rio Grande do Sul-Hospital de Clínicas de Porto Alegre   

More Information

Study ID Numbers:  HCPA03287
Last Updated:  August 9, 2005
Record first received:  August 8, 2005
ClinicalTrials.gov Identifier:  NCT00128141
Health Authority: Brazil: Committee of Ethics in Research
ClinicalTrials.gov processed this record on 2005-08-23


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September 5, 2008



Page Updated: November 5, 2004
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