Vital Signs and stress behavior in preterm newborns undergoing to tub bath.

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2017
INTERVENTION: D04.808.745.745.654.600 E01.370.600.875.500 F01.145 G03.730 G07.110.232 Procedure/surgery The total number of 36 newborns will be allocated in two groups of 18 newborns, each which will be undergoing to swaddled immersion bath in a sheet ‐ SIB (Experimental Group ‐ EG) as the conventional immersion bath ‐ CIB (Control Group ‐ CG ), following a randomization list in which the newborn will receive one type of bath per day, with a minimum interval of 24 hours between baths. As the study is crossover clinical trial, all newborns will receive the control and intervention baths according to the randomization list. In both types of bath will be measured the body temperatures, heart rate, oxygen saturation immediately before the bath, 10 and 20 minutes after bathing. Saliva samples will be collected before and 20 minutes after bathing. To evaluate the behavioral state, will be filmed 10 minutes before the bath and 20 minutes after bathing. Newborns undergoing to conventional immersion bath (CIB) and swaddle (SIB) will have their trunks and immersed limbs, head and neck supported in the caregiver hand. With the trunk, limbs and the dorsal and lumbar regions of the newborn immersed in water, the caregiver lather these body regions. To neonates undergoing the swaddled immersion bath, the caregiver will remove the sheet that surrounds the body of the newborn, with the newborn immersed in water, as for lathering each body part. A minimum time interval to be consumed for the immersion bath between 7 minutes will be established and a maximum of 10 minutes (Loring et al., 2012). Before starting the bath, doors and hospital room windows of the newborn will be closed, avoiding airstreams to ensure that the environmental temperature remains between 24 ° C and 28 ° C (Brazil, 2011). If the environmental temperature be lower than 24ºC, it will be provided warmer environment, kept close to the location of the bath. Then it will be measured the temperature of bath water with own thermometer. The neonate will be immersed in water temperature between 38 ° C and 40 ° C (Lee, 200 VS2.003.003.001 CONDITION: Body temperature regulation, heart rate,oxygen consumption, hydrocortisone levels and behavior in preterm infants ; G07.110.232 ; E01.370.600.875.500 ; G03.730 ; D04.808.745.745.654.600 ; F01.145 D04.808.745.745.654.600 E01.370.600.875.500 F01.145 G03.730 G07.110.232 PRIMARY OUTCOME: Axillary temperature variation 10 and 30 minutes post immersion bath compared to axillary temperature immediately pre bath, measured by a digital thermometer in Celsius degree.; SECONDARY OUTCOME: Heart rate variation 10 and 30 minutes post immersion bath compared to heart rate values immediately pre bath. The heart rate will be measured by a multiparametrical monitor put in one of the newborn lower limbs. ; Oxygen saturation variation 10 and 30 minutes post immersion bath compared to oxygen saturation values immediately pre bath. The oxygen saturation will be measured by a multiparametrical monitor put in one of the newborn lower limbs. ; Salivary cortisol variation 20 minutes post bath compared to values pre bath. The salivary cortisol will be collected by a ophthalmic sponge which will be keep up for 10 minutes in one of the corners of the mouth to obtain at least 1 ml of saliva. ; Clinically stable with heart rate between 120‐160 and oxygen saturation greater than 85% whitin 6 hour prior to data collection (immersion bath) and infants fed for at least 1 hour ; Sleep‐wake state variation of preterm newborn 10 minutes pre bath compared to sleep‐wake state 20 minutes post bath. The sleep‐wake state will be filmed for 10 minutes pre bath and for 20 minutes post bath. INCLUSION CRITERIA: Maximum adjusted gestational age of 36 weeks and 6 full days on the date of data collection;Preterm newborn over 24 hours of life;Spontaneous breathing;Release to immersion bath;No diagnosis of congenital anomalies and heart disease;Newborns no in use of sedative medication;Newborns who are not in the postoperative period;
Epistemonikos ID: b38a4b725917e22501a60001da1c160fa14fb2bb
First added on: Aug 23, 2024