Infant, Premature
Conditions
Interventions
This is a randomized, controlled, crossover and open clinical trial. The pilot will be carried out with 60 preterm newborns (PTNB). The sample calculation will take into account a 5% significance leve
G11.561.645
Sponsors
Universidade Estadual de Feira de Santana
Universidade Estadual de Feira de Santana
Eligibility
Age
7 Days to No maximum
Inclusion criteria
Inclusion criteria: Gestational age less than 37 weeks; after seven days of life; clinically stable (heart rate between 120 and 180 beats per minute, respiratory rate between 35 and 60 breaths per minute and oxygen saturation greater than or equal to 95% in the last 24 hours); kept inside incubators; 24 hours after the end of phototherapy treatment; both genders
Exclusion criteria
Exclusion criteria: In phototherapy; using invasive and non-invasive mechanical ventilation; with any type of congenital malformation; with periventricular hemorrhage grades II, III and IV; using central nervous system depressant medications, opioid analgesics and sedatives in the last 24 hours; using corticosteroids; in need of surgery of any nature; whose mother has a history of using any illicit drugs or antidepressants during pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that the use of eye protectors and ear protectors will help in the clinical evolution of premature newborns with stability of vital signs and a prolonged sleep state with reduced interference from stress factors, such as noise and light. Furthermore, quantify the level of noise and light with the aim of promoting educational measures with methods that mitigate their effects. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected. | — |
Countries
Brazil
Contacts
Public ContactCleonara Ferreira
Universidade Estadual de Feira de Santana
Outcome results
None listed