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Prematurity

Prematurity: risk factors and childhood development

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-536yfm
Enrollment
Unknown
Registered
2020-05-06
Start date
2020-06-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neonatology

Interventions

Newborns after randomization will be submitted to respiratory biomechanical techniques such as muscle stretching, diaphragmatic stimulation or thoracoabominal support, according to allocation. The fre
Other
E02.779

Sponsors

Universidade Federal de Santa Catarina
Lead Sponsor
Universidade Federal de Santa Catarina
Collaborator

Eligibility

Age
24 Weeks to 36 Weeks

Inclusion criteria

Inclusion criteria: The studied patients will be preterm newborns; and with gestational age equal to or greater than 24; and minimum corrected age of 32 weeks; of both sexes; admitted to the Intensive Care Unit; and / or in the joint accommodation; with a current weight equal to or greater than 1500g; clinically stable; and hemodynamically; and breathing in ambient air; at the time of assessment, these being the study inclusion criteria.

Exclusion criteria

Exclusion criteria: Newborns with congenital malformations will be excluded; or genetic syndrome that compromises respiratory biomechanics; and congenital heart diseases

Design outcomes

Primary

MeasureTime frame
Evaluate the heart rate variability, measured by the cardiofrequencimeter in heartbeat interval, considering the variables SDNN, SDANN, SDNNi, rMSSD and pNN50, a very low frequency and ultra low frequency component; 2) Low frequency component; 3) High frequency component and Chaos Theory. The evaluations will take place at rest for 60 seconds, during the intervention and 60 seconds after the intervention. The variables will be checked even during hospitalization in the neonatal intensive care unit or rooming-in and after 1 month of hospital discharge;Assess the respiratory rate, considered as a measure of the amount of breath per minute that will be obtained at rest, during the application of the techniques and after the procedure by counting the breath with a timer for 60 seconds. The variables will be checked even during hospitalization in the neonatal intensive care unit or rooming-in and after 1 month of hospital discharge.

Secondary

MeasureTime frame
Assess respiratory distress using the respiratory assessment scale for children, with a score of 8 - 10 = Severe respiratory distress; 4 - 7 = Moderate respiratory distress; 1 - 3 = Mild discomfort; Zero = without respiratory distress and will be obtained at rest, during the application of the techniques and after the procedure through the analysis of the collection video. The variables will be checked even during hospitalization in the neonatal intensive care unit or rooming-in and after 1 month of hospital discharge.;To evaluate respiratory distress by the Silverman-Andersen Bulletin, being classified as 10 points, corresponding to the maximum degree of respiratory distress, a score below 5 points indicates a slight difficulty and will be obtained at rest, during the application of the techniques and after procedure by analyzing the collection video. The variables will be checked even during hospitalization in the neonatal intensive care unit or rooming-in and after 1 month of hospital discharge.;Assess blood pressure, measured as systolic and diastolic pressure, in millimeters of mercury, which will be obtained at rest, during the application of the techniques and after the procedure through the multiparametric monitor. The variables will be checked even during hospitalization in the neonatal intensive care unit or rooming-in and after 1 month of hospital discharge.;Evaluate the heart rate, measured by the heartbeat per minute that will be obtained at rest, during the application of the techniques and after the procedure through the multiparametric monitor. The variables will be checked even during hospitalization in the neonatal intensive care unit or rooming-in and after 1 month of hospital discharge.;Evaluate the oxygen saturation, a measure of the percentage of oxygen that the blood is carrying and will be obtained at rest, during the application of the techniques and after the procedure through the multiparametric monitor. The variables will be checked

Countries

Brazil

Contacts

Public ContactCristiane Moran

Universidade Federal de Santa Catarina

cristianemoran@gmail.com+5548996647756

Outcome results

None listed

Source: REBEC (via WHO ICTRP)