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Effects of two placements on the behavior of preterm infants.

Effects of positioning on dorsal and right lateral decubitus on behavioral and physiological indicators of preterm newborns.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3jjbs2
Enrollment
Unknown
Registered
2018-09-14
Start date
2017-01-14
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

Changes in the development of preterm newborns when compared to behavioral and physiological indicators during hospitalization in an Intermediate Care Unit

Interventions

Place of intervention: Neonatal Intermediate Care Unit (NICU) Procedure: nest position in right lateral decubitus (RLD) and dorsal decubitus (DD). Participants: 30 premature newborns, randomized int
Behavioural

Sponsors

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Lead Sponsor
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Collaborator
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Collaborator

Eligibility

Age
32 Weeks to 36 Weeks

Inclusion criteria

Inclusion criteria: Pre-term with post-conceptual age on the day of intervention between 32 and 36 weeks and 6 days; Of both sexes; Postnatal age> 24 hours; Clinically stable (free of intravenous access, in ambient air and oral feeding, by nasogastric or orogastric tube; In the case of twins, only one was chosen by lot.

Exclusion criteria

Exclusion criteria: They presented neurological impairment (hydrocephalus, microcephaly, periventricular hemorrhage grades III and IV and brachial plexus lesion; With congenital malformation (myelomeningocele, encephalocele, agenesias and focomelias, among others); With suspicion of some kind of genetic alteration; With sensorial alterations (visual and auditory); With orthopedic alterations; With viral, bacterial or congenital infections; With an Apgar score equal to or less than 4, at 5 minutes, suggestive of choking; Or whose mothers abused toxic substances during pregnancy.

Design outcomes

Primary

MeasureTime frame
Nest placement in the DLD compared to DD will provide the preterm infant with lower behavioral activation, longer stay in organized sleep or wake states, as well as more adequate levels of heart rate and higher levels of peripheral saturation. For the categorical variables of the behavioral states, the conversion was done in percentage of time in maintenance in the states of sleep and wakefulness. For the characterization variables of the sample, the analysis was performed in terms of percentage and prevalence. Numerical variables were analyzed in terms of mean, standard deviation, median and maximum and minimum values. This descriptive analysis was performed for the entire sample and also for the randomized groups in relation to the order of decubitus. The following variables were considered as behavioral indicators: mean of wakefulness and sleep states calculated by means of the 30 observation measures; percentage of maintenance in sleep states including deep sleep, light sleep and drowsiness; percentage of maintenance in alert states encompassing inactive alert and active alert; percentage of maintenance in the crying state. As physiological indicators, the mean heart rate and peripheral oxygen saturation were considered. For all variables, the two decubits studied were analyzed. After a detailed description of the data, the comparison of the groups was done through the adjustment of linear models of mixed effects, which consider a random effect that contemplates the dependence between observations measured in the same individual. At first, a model was fitted without considering the effect of position sequence and, subsequently, that effect was inserted into the fit. The software used was SAS 9.4.

Secondary

MeasureTime frame
Secondary outcomes are not expected.

Countries

Brazil

Contacts

Public ContactGabrielle Nogueira

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

gabriellemn@hotmail.com+5516981417160

Outcome results

None listed

Source: REBEC (via WHO ICTRP)