Effect of Tactile and Kinesthetic Stimulation on Very Low Birth Weight Preterm Infants
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Preterm Birth |
Behavioral: Tactile stimulus |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Maternal Tactile and Kinesthetic Stimulation on Length of Hospital Stay of Very Low Birth Weight Infants |
- length of hospital stay [ Designated as safety issue: No ]
- effect on beginning of enteral feedings [ Designated as safety issue: No ]
- growth during hospitalization [ Designated as safety issue: No ]
| Enrollment: | 104 |
| Study Start Date: | August 2003 |
| Study Completion Date: | November 2005 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: 1 | |
|
Experimental: 2
tactile stimulus
|
Behavioral: Tactile stimulus
four times a day
Other Name: massage therapy
|
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.
Eligibility| Ages Eligible for Study: | up to 3 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Brazil | |
| Hospital de Clínicas de Porto Alegre | |
| Porto Alegre, RS, Brazil, 90035-005 | |
| Principal Investigator: | Renato S Procianoy, MD | Universidade Federal do Rio Grande do Sul-Hospital de Clínicas de Porto Alegre |
More Information
No publications provided
| Responsible Party: | Renato S. Procianoy, Hospital de Clinicas de Porto Alegrte |
| ClinicalTrials.gov Identifier: | NCT00128141 History of Changes |
| Other Study ID Numbers: | HCPA03287 |
| Study First Received: | August 8, 2005 |
| Last Updated: | February 4, 2008 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Additional relevant MeSH terms:
|
Birth Weight Premature Birth Body Weight Signs and Symptoms |
Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |
ClinicalTrials.gov processed this record on May 19, 2013