Birth Premature
Conditions
Interventions
This is a randomized, single-blind, non-inferiority, controlled clinical trial with two parallel groups and a 1:1 allocation ratio. The described research will be conducted in the Neonatal Intensive C
of both sexes, older than 72 hours, with a body weight above 1,100g, and presenting hemodynamic and clinical stability. The sample will consist of 84 participants, divided into two groups: 42 in the I
s initial assessment and delivered to the intervention supervisor. The supervisor responsible for the assessment and the statistical analysis will be blinded to the study. Patients will undergo an ini
s facial activity, identifying and classifying pain levels (composed of 8 parameters). The reaction to touch will also be evaluated by the presence or absence of signs of withdrawal, in addition to mo
Sponsors
Empresa Brasileira de Serviços Hospitalares - EBSERH
Universidade Federal do Amapá
Eligibility
Age
28 Weeks to 36 Weeks
Inclusion criteria
Inclusion criteria: Preterm newborns admitted to the Neonatal Intensive Care Unit of the Hospital da Mulher Mãe Luzia will be included in the study provided they are born with a gestational age between 28 and 36 weeks; with a corrected gestational age of 32 weeks or more; with an Apgar score greater than 6 at 1 and 5 minutes; of both sexes; older than 72 hours; with a body weight above 1.100g; presenting hemodynamic and clinical stability; receiving full enteral nutrition; via nasogastric or orogastric tube; or breastfeeding; in an incubator or crib; breathing room air or receiving support such as non invasive ventilation and oxygen supplementation
Exclusion criteria
Exclusion criteria: Preterm newborns will be excluded from the study if they present with congenital malformations; genetic syndromes; worsening of the underlying disease; hemodynamic and clinical instability; hypothermia; use of sedatives; thrombocytopenia with a value lower than 50.000; active hemorrhage; peri intraventricular hemorrhage; are on invasive mechanical ventilation; have a positive C Reactive Protein test; are in contact isolation or have experienced a cardiorespiratory arrest in the last 24 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primarily, the motor behavior of the preterm newborn will be evaluated using the Test of Infant Motor Performance, it is expected that there will be an improvement in motor response and organization of spontaneous and reactive movements through the impact of the techniques applied in this study, generating an increase in their score to bring them closer to the average established for each specific age, as described in the test's scoring table. This data will be collected before and after 5 days of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| For secondary outcomes, stress levels will be assessed using the Neonatal Facial Coding System, where newborns are expected to score less than 3, additionally, clinical signs of reaction to touch will be evaluated through signs of withdrawal, complementing the stress assessment. This data will be collected daily for 5 days of intervention and will also be part of the initial and final evaluations of the study | — |
Countries
Brazil
Contacts
Public ContactLarissa Matias
Universidade Federal do Amapá
Outcome results
None listed