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Completed

NCT Number: NCT00128141

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

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 hour–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-005, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tactile stimulus

Behavioral

four times a day

Other names: massage therapy

Primary outcomes

  1. length of hospital stay

Secondary outcomes

  1. effect on beginning of enteral feedings

  2. growth during hospitalization

Sponsors and collaborators

Lead sponsor

National Bioethics Commission of Brazil

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Aug 9, 2005
Registry last updated
Feb 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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