Brain Injuries Diffuse
Conditions
Interventions
This is a randomized crossover clinical trial in two periods, with single blinding, where participants receive two treatments sequentially during two periods and the order in which the treatments are
Sponsors
Faculdade de Medicina da Universidade de São Paulo
Hospital Albert Einstein
Eligibility
Age
No minimum to 35 Weeks
Inclusion criteria
Inclusion criteria: Newborns under 35 weeks admitted to the Neonatal Intensive Care Unit; both genders; monitored with brain near-infrared light spectroscopy
Exclusion criteria
Exclusion criteria: Congenital Heart Disease; diaphragmatic hernia; fracture of upper limbs or lower limbs; use of sedation or analgesics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the variation in regional oxygen saturation of brain tissue, determined using NIRS (Near Infrared Light Spectrometry), 10 minutes before suction of secretions present from the upper airways, up to 1 minute after suction and 10 minutes after suction, aspiration both with facilitated tucking and without facilitated tucking. It is expected to find a smaller variation in regional oxygen saturation of brain tissue with the use of facilitated tucking during the procedure for suction of secretions present in the upper airways | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the variation in peripheral arterial oxygen saturation (SatO2), determined using a pulse oximeter, 10 minutes before suction of secretions present from the upper airways, up to 1 minute after suction and 10 minutes after suction, aspiration both with facilitated tucking and without facilitated tucking. It is expected to find a smaller variation in peripheral arterial oxygen saturation with the use of facilitated tucking during the procedure for suction of secretions present in the upper airways;Evaluate the variation of the NIPS scale of the English Neonatal Infant Pain Scale, 10 minutes before suction of secretions present from the upper airways, up to 1 minute after suction and 10 minutes after suction, aspiration both with facilitated tucking and without facilitated tucking. It is expected to find a lower NIPS scale score with the use of facilitated tucking during the procedure for suction of secretions present in the upper airways;Evaluate the variation in heart rate (beats per minute), determined using a cardiac monitor, 10 minutes before suction of secretions present from the upper airways, up to 1 minute after suction and 10 minutes after suction, aspiration both with facilitated tucking and without facilitated tucking. It is expected to find a smaller variation in heart rate with the use of facilitated tucking during the procedure for suction of secretions present in the upper airways;Evaluate the variation in non-invasive mean arterial pressure (millimeters of mercury - mmHg), determined using a cardiac monitor,10 minutes before suction of secretions present from the upper airways, up to 1 minute after suction and 10 minutes after suction, aspiration both with facilitated tucking and without facilitated tucking. It is expected to find a smaller variation in non-invasive mean arterial pressure with the use of facilitated tucking during the procedure for suction of secretions present in the upper airways | — |
Countries
Brazil
Contacts
Public ContactEvelim Gomes
Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed