Main
|
Note: This record shows only 22 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:
|
29 May 2023 |
Main ID: |
RBR-244gpz |
Date of registration:
|
12/04/2016 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Influence of exercises performed by physiotherapists in newborns prematuos to improve breathing
|
Scientific title:
|
Influence of sensorimotor stimulation of the respiratory system of preterm infants |
Date of first enrolment:
|
13/04/2015 |
Target sample size:
|
|
Recruitment status: |
Data analysis completed |
URL:
|
http://ensaiosclinicos.gov.br/rg/RBR-244gpz |
Study type:
|
Intervention |
Study design:
|
Clinical trial treatment , open-label, single group.
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Brazil
| | | | | | | |
Contacts
|
Name:
|
Natália Matos
Tedesco |
Address:
|
Dr. Julio de Almeida, nº 50
79050-650
Campo Grande
Brazil |
Telephone:
|
+556781175105 |
Email:
|
na_tedesco@hotmail.com |
Affiliation:
|
Universidade Federal do Mato Grosso do Sul |
|
Name:
|
Geisy Hellen Mamedes
Silva |
Address:
|
Dr. Julio de Almeida, 50
79050-650
Campo Grande
Brazil |
Telephone:
|
+556781252870 |
Email:
|
geisy.hellen@hotmail.com |
Affiliation:
|
Universidade Federal do Mato Grosso do Sul |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: Gestational age 28semanas up to 36 weeks and 6 days; hemodynamically stable ; over 72 hours of life ; breathing spontaneously and may or may not be with O2 catheter use; no congenital malformations ; minimum weight of 1,100 grams.
Exclusion criteria: Patients with congenital malformations ; hemodynamically unstable ; intraventricular hemorrhage Peri grade III and / or IV ; weight loss.
Age minimum:
28W
Age maximum:
37W
Gender:
-
|
Health Condition(s) or Problem(s) studied
|
Premature, Newborn
|
M01.060.703.520
|
M01.060.703.520.520
|
Intervention(s)
|
Behavioural
|
Interventions occur within a hospital setting, Regional Hospital of Mato Grosso do Sul, which authorized the research in care and Intermediate Unit Kangaroo units.
The stimulation protocol sensorimotor, contains therapeutic exercises Baby Bobath method, being used some specific that could contribute to the improvement of respiratory mechanics of preterm infants, as follows: trunk dissociation, kicks and alternating range, feel the head hands, facial stimulation and supine positioning.
The exercises were always performed by the same physical therapist, in the evening , 60 minutes after the diet offer once a day for 10 minutes for 3 consecutive days , each period lasted on average 2 to 2.5 minutes and were only made after the head of the newborn sign the free and informed conscentimento term .
The data for analysis were collected through observation of the researchers, being the respiratory rate and the Silverman-Andersen newsletter. Other data were collected from the pulse oximeter, namely heart rate and oxygen saturation. These data were collected at three different times in the day, before the intervention, immediately after completion and 15 minutes after the end of the intervention. the team was requested and responsible that during the 15 minutes after the end of the intervention, not to perform any procedure with the newborn, not to interfere in the parameters analyzed.
We evaluated a total of 50 preterm infants who were admitted to the Intermediate Care Units and Unit Kangaroo Regional Hospital, who were hemodynamically stable with over 72 hours of life , whose responsible accept that their children participate in the intervention.
|
E02.779
|
E05.723
|
Primary Outcome(s)
|
The outcome at the end of the study was : Fall respiratory rate after the 15 minutes after the intervention in relation to initial respiratory rate . Fall respiratory rate on the 3rd day of action on the other two days and the value was lower at all times . Increased oxygen saturation at the time immediately after completion of the intervention. There was no change in heart rate . There was no significant change in the Silverman - andersann newsletter. Weight was up .
|
It was expected that sensorimotor stimulation exert influence on the physiological parameters of premature newborns.
To verify that this actually occur , the parameters analyzed were: heart rate ; respiratory frequency; oxygen saturation; Bulletin silverman - andersann and weight. All valued at 3 times : before the intervention , immediately after completion , and 15 minutes after completion . The weight was measured from one day to another.
|
Secondary Outcome(s)
|
To check the expected outcome , we use specific parameters that were analyzed , and these , heart rate, respiratory rate , oxygen saturation , silverman - andersann form and weight. As everyone except the weight analyzed before the start of the intervention , immediately after completion and 15 minutes after completion . The weight was checked only daily.
And among the outcomes that was not expected , but we could observe was that as happened to exchange the route of feeding preterm infants , the probe into her womb , occurred a loss of weight as a greater energy expenditure is needed must then exclude the premature newborn research
|
Source(s) of Monetary Support
|
Universidade Federal do Mato Grosso do Sul
|
Hospital Regional de Mato Grosso do Sul
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|