Influence of prone posture and hand asleep and vital signs of infants born preterm

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-7d3kdn
• Date of registration: 19/05/2015
• Prospective Registration: No
• Primary sponsor: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo
• Public title: Influence of prone posture and hand asleep and vital signs of infants born preterm
• Scientific title: Comparison of physiological and behavioral parameters between preterm infants placed in the prone and lateral (crossover design)
• Date of first enrolment: 04/01/2013
• Recruitment status: Recruitment completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-7d3kdn
• Study type: Intervention
• Study design: Clinical trial, intervention, focusing on prevention, crossed, with two arms, open, randomized crossover cross.
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Inalu Barbosa da Silva
• Affiliation: Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo

• Name: Inalu Barbosa da Silva
• Affiliation: Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo

Key inclusion & exclusion criteria

Inclusion criteria: Were included in the study, premature babies, with post-conceptional age greater than or equal to 32 weeks and <37 weeks and postnatal age> 24 hours, of both sexes, in the case of twins, only one was chosen by lot.
Exclusion criteria: Were excluded from the study, infants who present neurological impairment (hydrocephalus, microcephaly, periventricular hemorrhage grades III and IV and brachial plexus injury); who are making use of vasoactive drugs, central nervous system depressant that would influence or sleep; with congenital malformation (myelomeningocele, encephalocele, and agenesis focomielias); suspected of having some form of genetic alteration (no syndrome); changes with sensory (visual and auditory); with orthopedic disorders; with viral, bacterial or congenital infections (sepsis and meningitis); with herpes or syphilis; with Apgar scores of 4 or less in the 5th minute suggestive of suffocation; whose mothers abused intoxicants; sedated; coma.

Age minimum: 24H
Age maximum: 37W
Gender: -

Health Condition(s) or Problem(s) studied

F01.525.200

M01.060.703.520.520

Premature; sleep; prone position; child development

F02.830.855

G11.427.695.525

Intervention(s)

E02.760.670

Behavioural

The intervention was performed by placement in baby nest in two decubitus, the ventral (DV) and the right side (DLD), and randomized the order of decubitus. The placement was carried out only one single time. The start position of the collection was determined by lot, so when it began in ventral followed up with the side and back, featuring a crossover design, where the baby was control of himself. Thus, we evaluated 37 infants: 18 first placed in DV followed by DLD and 19 positioned in order inversa.Os babies were not in coils at the time of intervention. They remained for 30 minutes in each posture and were monitored with pulse oximetry to record heart rate (HR) and oxygen saturation (SpO2), and being under direct observation to record the states of wakefulness and sleep. HR and SpO2 were checked minutely and standby and sleep 30 in 30 seconds in statement prepared for this purpose.

Primary Outcome(s)

Expected outcome: greater permanence in the states of sleep positioning on nest in the prone position compared to the right lateral decubitus, verified by observing the state of wakefulness and sleep measured on an ordinal scale ranging from 0 to 6 behavioral activation.

Outcome found: the positioning nest in the prone position favored the maintenance in the states of sleep (deep sleep, active sleep and sleepiness) and maintaining the uninterrupted deep sleep state with respect to the lateral position.

Secondary Outcome(s)

Expected outcome: adequate levels of heart rate and higher levels of peripheral oxygen saturation in positioning nest in the prone position with respect to the lateral position.

Outcome found: there was no clinically relevant difference between the positioning nest prone and lateral position, considering the heart rate and oxygen saturation measured in 30 minutes of observation.

Source(s) of Monetary Support

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Secondary Sponsor(s)

Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo