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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: REBEC
Last refreshed on: 27 May 2013
Main ID:  RBR-7wm8mz
Date of registration: 28/02/2013
Primary sponsor: Faculdade Medicina Ribeirão Preto - USP - Ribeirão Preto, SP, Brazil
Public title: Response Oxygenation in Premature Newborns with use of Thoracic Elastic Band Positions in Two Body
Scientific title: Effect of Posture Positioning Front Support from Gradil Costal Premature Newborn
Date of first enrolment: 04/04/2010
Target sample size: 16
Recruitment status: data analysis completed
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-7wm8mz/
Study type:  Intervention
Study design:  Study with randomized, clinical trial, a prospective, randomized, crossover  
Countries of recruitment
Brazil
Contacts
Name: Marisa  Brunherotti
Address:  Rua Padres Agostinianos, 1265 14401-380 Franca - São Paulo Brazil
Telephone: +55(16)8112-7768
Email: brunherotti@uol.com.br
Affiliation:  Universidade de Franca
Name: Marisa  Brunherotti
Address:  Rua Padres Agostinianos, 1265 14401-380 Franca - São Paulo Brazil
Telephone: +55(16)8112-7768
Email: brunherotti@uol.com.br
Affiliation:  Universidade de Franca
Key inclusion & exclusion criteria
Inclusion criteria: Newborn premature birth with a minimum weight of 1200g and maximum of 2500g the gestational age of 36 weeks maximum, without ventilatory pressure and without supplemental oxygen, without infection and with good general
Exclusion criteria: Newborns classified as extremely premature, history of apnea, heart disease, congenital malformations, severe anoxia, hydrocephalus, post-abdominal surgery, neonatal infection, term newborns, ranked small for gestational age, use of ventilation system positive pressure

Age minimum: 31W
Age maximum: 36W
Gender: -
Health Condition(s) or Problem(s) studied
Newborn preterm
G09.772.770.755.700
C13.703.420.491.500
Intervention(s)
The study was conducted in humans. Newborns weighing at least 1.445ge and maximum 2.270ge gestational age 31-35 weeks, without ventilatory pressure and without supplemental oxygen, without blood count changes in cellularity red and white, being in the sector for weight gain. To stabilize the rib cage of newborns, we used the elastic band thoracic (38% cotton, 34% nylon and 28% elastodiene), marked in centimeters horizontally. The chest was wrapped by the band at the end of the inspiratory cycle of movement from this point, the closure strip during the second marking cm. The track was positioned below the nipple line up below the scar onfálica.The preterm infants who participated in this study were submitted to the sequence of postural positions, supine and prone positions. The newborns were subjected both positions by modifying them with and without stabilization of the chest, through the elastic band. So was used to randomly through the draw for the choice of the sequence. The criteria of the study was like "crossover". The same child was exposed to four events, so each child was observed alternately in the following positions: A - Supine without band, B - Supine with band, C - Prona without band, D - Prona with band. We used the sequences 1, 2, 3 and 4 (Sequence 1. A, D, C, B. Sequence 2. C, A, B, D. Sequence 3. B, C, D, A. Sequence 4. D B, A, C)
Primary Outcome(s)
Oxygen saturation values in this study was higher in body positioning that used to stabilize the rib cage through the elastic band
Secondary Outcome(s)
The respiratory rate and heart rate showed with values smaller in body positions that used the elastic band chest
Secondary ID(s)
024/2008
CAAE 0002.0.393.000-08
Source(s) of Monetary Support
CAPES - Brasilia, DF, Brazil
Secondary Sponsor(s)
Universidade de Franca - Franca, SP, Brazil
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