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-7jwsf6 |
Date of registration:
|
04/12/2014 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Methods of feeding the premature newborn
|
Scientific title:
|
Methods transition of offer of diet to premature newborn |
Date of first enrolment:
|
10/02/2014 |
Target sample size:
|
|
Recruitment status: |
Recruitment completed |
URL:
|
http://ensaiosclinicos.gov.br/rg/RBR-7jwsf6 |
Study type:
|
Intervention |
Study design:
|
Clinical trial interventions , prognosis , parallel with three arms, unicego , randomized controlled , prospective
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Brazil
| | | | | | | |
Contacts
|
Name:
|
Viviane Castro de
Araújo |
Address:
|
Rua Alexandre Guimarães, 1927
76801-101
Porto Velho
Brazil |
Telephone:
|
+55(69)32118035 |
Email:
|
araujocviviane@gmail.com |
Affiliation:
|
Faculdade São Lucas |
|
Name:
|
Viviane Castro de
Araújo |
Address:
|
Rua Alexandre Guimarães, 1927
76801-101
Porto Velho
Brazil |
Telephone:
|
+55(69)32118035 |
Email:
|
araujocviviane@gmail.com |
Affiliation:
|
Faculdade São Lucas |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: Will be included in newborns and preterm infants of both genders, with a gestational age of at least 32 weeks in the sample and
maximum of 36 weeks, appropriate for gestational age, who have not received oral diet weight. The mothers of these infants
will necessarily express the desire to breastfeed your child breastfed.
Exclusion criteria: Infants with gestational age less than 32 weeks or greater than 37 weeks, small or large for gestational age are excluded,
who have received oral diet, as well as infants who show any neurological abnormalities (including bleeding
peri-grades III and IV intraventricular and periventricular leukomalacia), chronic pulmonary distress, congenital heart defects, craniofacial malformation and
positive serum with human immunodeficiency virus. The mothers who did not express an interest in breastfeeding will also be considered to
child or are not watching their children due to hospitalization, death, come from another city.
Age minimum:
32W
Age maximum:
36W
Gender:
-
|
Health Condition(s) or Problem(s) studied
|
M01.060.703.520.520
|
F01.145.113.547
|
feeding behavior; infant, premature; infant,newborn
|
Intervention(s)
|
Participate in this study 90 infants with gestational age at less than 37 weeks and above and equal to 32 weeks birth. The sampling is random, stratified into blocks and, for the 90 infants are divided into three groups according to the method given power, group 1, 30 subjects who receive diet through the glass; Group 2 individuals receive diet 30 through the syringe; 30 individuals who will receive the diet-finger probe technique. Being Cup (Group 1) the method recommended by the Ministry of Health, will be considered as a control group and the other two methods (syringe, group 2 and probe-finger technique, group 3) are considered experimental groups. Therefore, for group 1 (control group) will be accompanied by 30 children and will be held daily assessment of oral skills sucking, called non-nutritive sucking (no food supply). By using the cup method is measured the amount of diet accepts the occurrence of spillage of milk in feeding the elapsed time, the variation of vital parameters (oxygen saturation and heart rate) and finally the time the neonate takes to be powered exclusively by mouth without gavage. For group 2 (experimental group), 30 children will be monitored and will be held daily assessment of oral skills sucking, called non-nutritive sucking. By using the syringe method is measured the amount of diet accepts the occurrence of spillage of milk in feeding the elapsed time, the variation of vital parameters (oxygen saturation and heart rate) and finally the time the neonate takes to be powered exclusively by mouth without gavage. In group 3 (experimental group), 30 children will be monitored and will be held daily assessment of oral skills sucking, called non-nutritive sucking. Utilizing the technique finger-probe method to be measured amount
|
J01.494.300
|
G07.610.240
|
F01.145.113.547
|
Other
|
Primary Outcome(s)
|
Variation of milk spill, seen from the observation of 20 % of the amount of spill offered by the cup diet ; verified by syringe method based on the statement of shedding 10% of the amount offered diet ; and verified by probe - finger technique based on the statement of 1 % of the amount of spill offered diet.
|
Secondary Outcome(s)
|
Influence of gestational age, checked for gestational age preterm infants from the observation that the closer a gestational age of 32 weeks will be the largest spill of milk, the time elapsed during feeding, the variation of vital parameters and the time of transition from gavage to oral exclusive.
|
Source(s) of Monetary Support
|
Faculdade São Lucas
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|